This document outlines course schemes and syllabi for Master of Pharmacy programs at a technical university in India.
It provides details for internal assessments and end semester examinations over 4 semesters for courses in Pharmacology, including topics covered, credit points awarded, and assessment breakdown.
In the first 2 semesters, courses cover modern analytical techniques, advanced pharmacology, screening methods, cellular and molecular pharmacology, and experimental pharmacology. The third semester focuses on research methodology and a research work project. The final semester involves a research work colloquium and dissertation.
Specific courses in the first semester include Modern Pharmaceutical Analytical Techniques covering spectroscopy, chromatography, electrophoresis and other analytical methods;
This document outlines courses for the first two semesters of a Hospital Pharmacy program. Semester I includes courses in modern analytical techniques, pharmacotherapeutics, hospital and community pharmacy, manufacturing pharmacy, and a practical. Semester II includes courses in quality use of medicines, additional pharmacotherapeutics, pharmaceutical formulation and control, pharmacoepidemiology, economics, and another practical. It then provides more detailed descriptions of the objectives and content of courses in analytical techniques, pharmacotherapeutics I, and hospital and community pharmacy.
This book is the first in a series published by Wiley entitled Technologies for the Pharmaceutical Industry. The series aims to bring opinion leaders together to address important topics for the industry, from technologies implemented to current challenges. It will describe how key technologies are likely to impact discovery and development. The book is split into five parts covering introduction to toxicology methods, computational methods, applying computers to toxicity assessment for pharmaceuticals and the environment, and new technologies, future perspectives and regulatory needs. Sean Ekins is the editor and his research focuses on computational and in vitro drug discovery approaches.
Analytical tech in pre formulation 112070804009Patel Parth
This document provides an overview of preformulation studies for new drug development. It discusses the need for preformulation to understand drug properties and design stable dosage forms. The stages of preformulation studies are outlined. A wide range of analytical techniques and instruments used in preformulation are described, including spectroscopic, separation, and thermal methods. Regulatory requirements for preformulation related to IND/NDA submissions and cGMP are also reviewed.
This document discusses recent advancements in impurity profiling. It defines impurity profiling and outlines the importance of identifying impurities. The history of instrumental analysis for impurity identification is reviewed. A systematic approach to impurity profiling is presented, including thresholds for identification, qualification, and reporting. Methods for isolation and identification of impurities are described, including case studies. Both classical and modern methodologies are covered, with examples of separation techniques like HPLC, TLC, and capillary electrophoresis.
BP 102 T PHARMACEUTICAL ANALYSIS I covers the fundamentals of analytical chemistry and principles of volumetric and electrochemical analysis of drugs. It focuses on understanding principles of various titration methods and developing analytical skills.
BP 701T INSTRUMENTAL METHODS OF ANALYSIS II deals with the application of instrumental methods like spectroscopy and chromatography in qualitative and quantitative drug analysis. It is designed to impart knowledge of principles and instrumentation of various analytical techniques and emphasizes theoretical and practical training for drug testing using modern instruments.
The two courses have different scopes, with BP 102 focusing on classical volumetric and electrochemical methods, while BP 701T focuses on instrumental methods of analysis like spectroscopy and
Pharmaceutical analysis involves analytical procedures to determine the purity, safety, and quality of drugs and chemicals. It is a branch of practical chemistry that identifies, quantifies, and purifies substances or separates mixtures. The objectives of the pharmaceutical analysis course are to understand principles of volumetric and electrochemical analysis and develop analytical skills. The course covers topics like sources of errors, primary and secondary standards, acid-base titrations, precipitation titrations, complexometric titration, and electrochemical methods of analysis. Pharmaceutical analysis is important for applications like quality control, clinical analysis, forensic analysis, and environmental analysis.
Chromatographic Analysis of Pharmaceuticals Second Edition by John A. AdamovicsRohit K.
This document is the preface to the second edition of the book "Chromatographic Analysis of Pharmaceuticals". It provides an overview of the changes and updates made for this new edition.
The first edition was published in 1990, and in the years since, the author has uncovered new examples and applications to include. The overall organization of chapters has been maintained, but some have been consolidated for better structure. Two new chapters on capillary electrophoresis and supercritical fluid chromatography have been added. All chapters have been updated with new information on protein pharmaceuticals.
This preface describes the motivation and goals for this new edition, which is to provide relevant information to chemists and biochemists working in pharmaceutical and bi
The document summarizes the synthesis and characterization of novel Cinnoline derivatives. Several students synthesized Cinnoline derivatives using Aniline as the starting material. The compounds were characterized using melting point, TLC, molecular formula determination, NMR and thin layer chromatography. The %yield of the compounds ranged from 82-93%. The compounds were further evaluated for their in-vitro antioxidant and antimicrobial activity. Pharmacological screening showed potential for treatment of fungal diseases.
This document outlines courses for the first two semesters of a Hospital Pharmacy program. Semester I includes courses in modern analytical techniques, pharmacotherapeutics, hospital and community pharmacy, manufacturing pharmacy, and a practical. Semester II includes courses in quality use of medicines, additional pharmacotherapeutics, pharmaceutical formulation and control, pharmacoepidemiology, economics, and another practical. It then provides more detailed descriptions of the objectives and content of courses in analytical techniques, pharmacotherapeutics I, and hospital and community pharmacy.
This book is the first in a series published by Wiley entitled Technologies for the Pharmaceutical Industry. The series aims to bring opinion leaders together to address important topics for the industry, from technologies implemented to current challenges. It will describe how key technologies are likely to impact discovery and development. The book is split into five parts covering introduction to toxicology methods, computational methods, applying computers to toxicity assessment for pharmaceuticals and the environment, and new technologies, future perspectives and regulatory needs. Sean Ekins is the editor and his research focuses on computational and in vitro drug discovery approaches.
Analytical tech in pre formulation 112070804009Patel Parth
This document provides an overview of preformulation studies for new drug development. It discusses the need for preformulation to understand drug properties and design stable dosage forms. The stages of preformulation studies are outlined. A wide range of analytical techniques and instruments used in preformulation are described, including spectroscopic, separation, and thermal methods. Regulatory requirements for preformulation related to IND/NDA submissions and cGMP are also reviewed.
This document discusses recent advancements in impurity profiling. It defines impurity profiling and outlines the importance of identifying impurities. The history of instrumental analysis for impurity identification is reviewed. A systematic approach to impurity profiling is presented, including thresholds for identification, qualification, and reporting. Methods for isolation and identification of impurities are described, including case studies. Both classical and modern methodologies are covered, with examples of separation techniques like HPLC, TLC, and capillary electrophoresis.
BP 102 T PHARMACEUTICAL ANALYSIS I covers the fundamentals of analytical chemistry and principles of volumetric and electrochemical analysis of drugs. It focuses on understanding principles of various titration methods and developing analytical skills.
BP 701T INSTRUMENTAL METHODS OF ANALYSIS II deals with the application of instrumental methods like spectroscopy and chromatography in qualitative and quantitative drug analysis. It is designed to impart knowledge of principles and instrumentation of various analytical techniques and emphasizes theoretical and practical training for drug testing using modern instruments.
The two courses have different scopes, with BP 102 focusing on classical volumetric and electrochemical methods, while BP 701T focuses on instrumental methods of analysis like spectroscopy and
Pharmaceutical analysis involves analytical procedures to determine the purity, safety, and quality of drugs and chemicals. It is a branch of practical chemistry that identifies, quantifies, and purifies substances or separates mixtures. The objectives of the pharmaceutical analysis course are to understand principles of volumetric and electrochemical analysis and develop analytical skills. The course covers topics like sources of errors, primary and secondary standards, acid-base titrations, precipitation titrations, complexometric titration, and electrochemical methods of analysis. Pharmaceutical analysis is important for applications like quality control, clinical analysis, forensic analysis, and environmental analysis.
Chromatographic Analysis of Pharmaceuticals Second Edition by John A. AdamovicsRohit K.
This document is the preface to the second edition of the book "Chromatographic Analysis of Pharmaceuticals". It provides an overview of the changes and updates made for this new edition.
The first edition was published in 1990, and in the years since, the author has uncovered new examples and applications to include. The overall organization of chapters has been maintained, but some have been consolidated for better structure. Two new chapters on capillary electrophoresis and supercritical fluid chromatography have been added. All chapters have been updated with new information on protein pharmaceuticals.
This preface describes the motivation and goals for this new edition, which is to provide relevant information to chemists and biochemists working in pharmaceutical and bi
The document summarizes the synthesis and characterization of novel Cinnoline derivatives. Several students synthesized Cinnoline derivatives using Aniline as the starting material. The compounds were characterized using melting point, TLC, molecular formula determination, NMR and thin layer chromatography. The %yield of the compounds ranged from 82-93%. The compounds were further evaluated for their in-vitro antioxidant and antimicrobial activity. Pharmacological screening showed potential for treatment of fungal diseases.
This document provides an overview of analytical chemistry and instrumentation. It defines pharmaceutical chemistry and analytical chemistry. It discusses qualitative and quantitative analysis and describes common analytical instruments like pH meters, ORP meters, gas chromatographs, mass spectrometers, and spectrometers. It also outlines the analytical methodology and lists some applications of instrumental methods in fields like bioanalysis, environmental analysis, materials science, and forensic science.
This is the presentation on Role of advancement in instrumentation in pharmacodynamic evaluation of drugs
in clinical trials.
CONTENTS
Concept of medical instrument and instrumentation
Centrifuge
PCR
HPLC
Flow cytometry
Mass SPECTROMETRY
Minimally invasive technologies in PD
Conclusion
The document provides an overview of preformulation studies. It discusses the importance of characterizing the physical and chemical properties of new drug molecules during preformulation to aid in the development of stable dosage forms. Some of the key areas covered include drug-excipient compatibility studies, stability kinetics testing, and determining properties like solubility, partition coefficient, and polymorphism that can help dictate the suitable dosage form. The goal of preformulation is to gather necessary data to rationally develop safe and efficacious dosage forms.
Crimson Publishers-Potential Application of Raman Micro-Spectroscopy as an In...CrimsonPublishersMAPP
Potential Application of Raman Micro-Spectroscopy as an In vitro Drug Screening and Companion Diagnostic Tool for Clinical Application: Chemotherapeutic Drug Mechanism of Action, Cellular Effects and Resistance by Z Farhane in Modern Applications in Pharmacy & Pharmacology
The document announces the inaugural Mass Spectrometry and Proteomics Congress to be held on November 14-15, 2016 in London. The conference will bring together experts in mass spectrometry to discuss latest developments in technologies and methods being used to advance medical research in areas such as disease diagnostics, metabolomics, proteomics, drug discovery, and genomics. It will include presentations on mass spectrometry strategies and technologies, related methodologies, and healthcare case studies and applications. Keynote speakers will discuss topics such as translational molecular imaging mass spectrometry and unlocking protein structure using 21 Tesla Fourier Transform Ion Cyclotron Resonance Mass Spectrometry.
The document presents information on an LC-MS/MS bioanalytical technique for quantifying the drugs encorafenib and binimetinib, which are used as a first-line treatment for advanced melanoma. It discusses developing and validating an LC-MS/MS method for analyzing the drugs in rat plasma. The method utilizes optimal chromatographic conditions and mass spectrometry detections to quantify the drugs down to 0.2 ng/mL within a 2-minute run time, making it effective for pharmacokinetic studies. The bioanalytical assay demonstrated appropriate extraction recovery and lack of matrix interference to efficiently determine pharmacokinetic parameters of the drugs following oral administration in rats.
ANALYTICAL TECHNIQUES (CHROMATOGRAPHY, SPECTROSCOPY, ELECTROPHOROSIS) IN PHAR...imran khan
This document reviews various analytical techniques used in pharmaceutical analysis, including chromatography, spectroscopy, and electrophoresis. It provides details on techniques such as thin layer chromatography, high-performance liquid chromatography, mass spectrometry, infrared spectroscopy, nuclear magnetic resonance spectroscopy, and discusses how these techniques are coupled with chromatography. The review highlights that analytical techniques play an important role in drug development and quality control, from understanding drug stability to quantifying impurities and ensuring proper drug content in marketed products.
1.preformulation concept in Modern pharmaceutics.pptxPNMallikarjun
Preformulation is defined as the investigation of physical and chemical properties of a drug substance alone and when combined with excipients. The goal is to generate information to help formulators develop stable and safe dosage forms with good bioavailability. Some key tests include determining the drug's solubility, stability, and compatibility with various excipients using techniques like DSC, TLC, and HPLC. This provides critical data to guide the rational selection of dosage form and formulation components.
This document provides information about the General Pharmacology course offered at the University of Zambia School of Medicine. The course is intended to provide students with a solid foundation in fundamental pharmacology concepts. Over the 14-week course, students will learn about how drugs act on major organ systems of the body like the nervous, cardiovascular, and gastrointestinal systems. Assessment will include tests, assignments, lab reports, seminars, and a final exam worth 60% comprising two papers. Students must achieve a minimum of 85% attendance and are responsible for all material covered.
METABOLOMICS is the systematic study of the small molecular metabolites in a cell, tissue, biofluid, or cell culture media that are the tangible result of cellular processes or responses to an environmental stress.
Evaluation methods for drug excipients and container interactionSagar Savale
This document discusses drug-excipient interactions, including the types (drug-excipient, drug-drug, excipient-excipient, drug-container), mechanisms (physical, chemical, physiological), and methods of evaluation such as differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), and Fourier transform infrared spectroscopy (FTIR). DSC is used to study thermal transitions like melting points and glass transition temperatures to detect interactions. XRPD provides information on crystalline structure and changes from interactions. FTIR detects changes in molecular vibrations from interactions. Together these methods help evaluate excipient compatibility and identify interactions.
Rudolf Buchheim founded the first institute of pharmacology in 1847, establishing pharmacology as an independent discipline. Oswald Schmiedeberg helped expand pharmacology in the late 19th century. Pharmacology studies drug action and interactions between chemicals and living organisms. It has broad applications in research, academics, and industries. The field continues to grow with new areas like pharmacogenomics, proteomics, and nanomedicine. Pharmacology also has many sub-disciplines that focus on specific organ systems or aspects of pharmacology.
This document outlines the course outcomes for various subjects across semesters of the B. Pharm. (PCI) syllabus at New Delhi. It lists the course outcomes for subjects like Human Anatomy and Physiology, Pharmaceutical Organic Chemistry, Biochemistry, Pathophysiology, Medicinal Chemistry, Physical Pharmaceutics, Pharmacology, Pharmacognosy, Herbal Drug Technology, Biopharmaceutics, Pharmacokinetics, Pharmaceutical Biotechnology and Quality Assurance across even semesters II, IV, VI and VIII. It also provides details of supportive staff for the course and concludes by stating that the next presentation will cover outcomes for odd semesters and framing of continuous assessment and practical internal exams.
B. pharm. course outcomes According to PCI syllabus fir NBASnehalChakorkar
This document outlines the course outcomes for various subjects across semesters in the B. Pharm. (PCI, New Delhi) syllabus. It lists the key learning objectives for each subject in the even semesters, including anatomy, physiology, organic chemistry, biochemistry, pathophysiology, pharmacology, and quality assurance. The objectives cover understanding concepts, mechanisms, classifications, summaries and applications of knowledge. It also recognizes the supportive staff involved in the program delivery.
B. pharm. course outcomes Even semester dr. amit gangwal & ms. s. s. chakorkarSnehalChakorkar
This document outlines the course outcomes for various subjects across semesters II, IV, VI, and VIII of the B. Pharm. (PCI) syllabus at New Delhi. It lists the key learning objectives for each subject in point form. The subjects covered include Human Anatomy and Physiology, Pharmaceutical Organic Chemistry, Biochemistry, Pathophysiology, Medicinal Chemistry, Physical Pharmaceutics, Pharmacology, Pharmacognosy, Herbal Drug Technology, Biopharmaceutics, Pharmaceutical Biotechnology, Quality Assurance, Biostatistics, Social and Preventive Pharmacy, and Pharmacovigilance. For each subject, 3-5 high-level course outcomes are provided relating to understanding concepts, mechanisms
This document outlines the syllabus for the subject Biopharmaceutics and Pharmacokinetics at Dr. Babasaheb Ambedkar Marathwada University. The syllabus covers 14 sections that include topics such as absorption, distribution, metabolism, elimination of drugs, pharmacokinetic models, bioavailability and bioequivalence. Some key areas covered are factors affecting drug absorption, distribution and elimination processes in the body, pharmacokinetic parameters and concepts such as volume of distribution, clearance and half-life. Mathematical treatments of compartment models and methods to determine pharmacokinetic parameters are also included.
PREFACE
Over the last few decades, the application of chemometric techniques to
all fields in analytical chemistry and particularly to analytical chromatography
and spectrometry has increased dramatically. The modern state and the novel
application fields of chemometrics, as an interdisciplinary and promising area,
have been transferred to legacy to many incoming young and experienced
analysts.
Considering chemometrics as an unavoidable part of experimental
design and data interpretation in personal work, the idea of writing this
monograph, as helpful supplement to common knowledge of chemometrics in
analytical chemistry, has originated.
It has been about 35 years since the first chemometric handbooks were
printed. Nowadays, everybody has to acknowledge a huge significance in
analytical chemistry and many related disciplines. The chemometric concept in
the most of these books has been presented to the readers in a manner that does
not assume a very good background in statistics or matrix algebra. Today
handbooks that are being printed present a huge effort to explain and clarify the
state of the art in chemometrics, so they can be highly recommended to anyone
working in this field.
This monograph represents the modest contribution to the modern
aspects of chemometrics, especially underlining the most popular methods and
scopes stuffed with comprehensive and useful examples of their practical
applications in analytical chemistry. Such monograph could be figured as useful
reading to a wide range of analytical chemistry practitioners who are not new in
this field but who simply need to have some specific aspects of chemometrics
all along in their everyday practice. Such aspects of this intricate and complex
matter are herein described in detail and designed to be easily reached and
understood.
Theoretical basics are explained and supported by practical examples in
a style that makes the material accessible to a broad audience of analytical
chemists. After all, this monograph certainly has been derived from a long-term
practical and theoretical work in this field and experience that has been gathered
on that road.
The monograph covers 12 chemometric fields of interest divided into 5
main chapters. Every chapter can be studied separately since it has been written
as a stand-along piece of text. This way, the reader could study every chapter as
a unity. Each topic is supported by basic theory, followed by several
representative examples. Some information are repeated in different places with
similar or different purpose so this hopefully could help the reader to recall or
rethink a topic in a different way.
Dr Antonije Onjia
This document describes an analytical toxicology report on the analysis of chemicals that may have adverse health effects. It discusses:
1. Analytical toxicology involves applying analytical chemistry tools to qualitatively and quantitatively analyze chemicals that could harm living organisms. This can help diagnose and prevent poisoning.
2. Several factors must be considered before analysis, like the amount of sample available and which poison is suspected. Samples like GI contents, urine, liver and concentrated tissues are analyzed depending on the poison.
3. Modern techniques like GC-MS and LC-MS are commonly used to simultaneously separate and quantify analytes. This report presents a real case study where these methods were used to detect anticoagulant rodent
This document provides an overview of analytical chemistry and instrumentation. It defines pharmaceutical chemistry and analytical chemistry. It discusses qualitative and quantitative analysis and describes common analytical instruments like pH meters, ORP meters, gas chromatographs, mass spectrometers, and spectrometers. It also outlines the analytical methodology and lists some applications of instrumental methods in fields like bioanalysis, environmental analysis, materials science, and forensic science.
This is the presentation on Role of advancement in instrumentation in pharmacodynamic evaluation of drugs
in clinical trials.
CONTENTS
Concept of medical instrument and instrumentation
Centrifuge
PCR
HPLC
Flow cytometry
Mass SPECTROMETRY
Minimally invasive technologies in PD
Conclusion
The document provides an overview of preformulation studies. It discusses the importance of characterizing the physical and chemical properties of new drug molecules during preformulation to aid in the development of stable dosage forms. Some of the key areas covered include drug-excipient compatibility studies, stability kinetics testing, and determining properties like solubility, partition coefficient, and polymorphism that can help dictate the suitable dosage form. The goal of preformulation is to gather necessary data to rationally develop safe and efficacious dosage forms.
Crimson Publishers-Potential Application of Raman Micro-Spectroscopy as an In...CrimsonPublishersMAPP
Potential Application of Raman Micro-Spectroscopy as an In vitro Drug Screening and Companion Diagnostic Tool for Clinical Application: Chemotherapeutic Drug Mechanism of Action, Cellular Effects and Resistance by Z Farhane in Modern Applications in Pharmacy & Pharmacology
The document announces the inaugural Mass Spectrometry and Proteomics Congress to be held on November 14-15, 2016 in London. The conference will bring together experts in mass spectrometry to discuss latest developments in technologies and methods being used to advance medical research in areas such as disease diagnostics, metabolomics, proteomics, drug discovery, and genomics. It will include presentations on mass spectrometry strategies and technologies, related methodologies, and healthcare case studies and applications. Keynote speakers will discuss topics such as translational molecular imaging mass spectrometry and unlocking protein structure using 21 Tesla Fourier Transform Ion Cyclotron Resonance Mass Spectrometry.
The document presents information on an LC-MS/MS bioanalytical technique for quantifying the drugs encorafenib and binimetinib, which are used as a first-line treatment for advanced melanoma. It discusses developing and validating an LC-MS/MS method for analyzing the drugs in rat plasma. The method utilizes optimal chromatographic conditions and mass spectrometry detections to quantify the drugs down to 0.2 ng/mL within a 2-minute run time, making it effective for pharmacokinetic studies. The bioanalytical assay demonstrated appropriate extraction recovery and lack of matrix interference to efficiently determine pharmacokinetic parameters of the drugs following oral administration in rats.
ANALYTICAL TECHNIQUES (CHROMATOGRAPHY, SPECTROSCOPY, ELECTROPHOROSIS) IN PHAR...imran khan
This document reviews various analytical techniques used in pharmaceutical analysis, including chromatography, spectroscopy, and electrophoresis. It provides details on techniques such as thin layer chromatography, high-performance liquid chromatography, mass spectrometry, infrared spectroscopy, nuclear magnetic resonance spectroscopy, and discusses how these techniques are coupled with chromatography. The review highlights that analytical techniques play an important role in drug development and quality control, from understanding drug stability to quantifying impurities and ensuring proper drug content in marketed products.
1.preformulation concept in Modern pharmaceutics.pptxPNMallikarjun
Preformulation is defined as the investigation of physical and chemical properties of a drug substance alone and when combined with excipients. The goal is to generate information to help formulators develop stable and safe dosage forms with good bioavailability. Some key tests include determining the drug's solubility, stability, and compatibility with various excipients using techniques like DSC, TLC, and HPLC. This provides critical data to guide the rational selection of dosage form and formulation components.
This document provides information about the General Pharmacology course offered at the University of Zambia School of Medicine. The course is intended to provide students with a solid foundation in fundamental pharmacology concepts. Over the 14-week course, students will learn about how drugs act on major organ systems of the body like the nervous, cardiovascular, and gastrointestinal systems. Assessment will include tests, assignments, lab reports, seminars, and a final exam worth 60% comprising two papers. Students must achieve a minimum of 85% attendance and are responsible for all material covered.
METABOLOMICS is the systematic study of the small molecular metabolites in a cell, tissue, biofluid, or cell culture media that are the tangible result of cellular processes or responses to an environmental stress.
Evaluation methods for drug excipients and container interactionSagar Savale
This document discusses drug-excipient interactions, including the types (drug-excipient, drug-drug, excipient-excipient, drug-container), mechanisms (physical, chemical, physiological), and methods of evaluation such as differential scanning calorimetry (DSC), X-ray powder diffraction (XRPD), and Fourier transform infrared spectroscopy (FTIR). DSC is used to study thermal transitions like melting points and glass transition temperatures to detect interactions. XRPD provides information on crystalline structure and changes from interactions. FTIR detects changes in molecular vibrations from interactions. Together these methods help evaluate excipient compatibility and identify interactions.
Rudolf Buchheim founded the first institute of pharmacology in 1847, establishing pharmacology as an independent discipline. Oswald Schmiedeberg helped expand pharmacology in the late 19th century. Pharmacology studies drug action and interactions between chemicals and living organisms. It has broad applications in research, academics, and industries. The field continues to grow with new areas like pharmacogenomics, proteomics, and nanomedicine. Pharmacology also has many sub-disciplines that focus on specific organ systems or aspects of pharmacology.
This document outlines the course outcomes for various subjects across semesters of the B. Pharm. (PCI) syllabus at New Delhi. It lists the course outcomes for subjects like Human Anatomy and Physiology, Pharmaceutical Organic Chemistry, Biochemistry, Pathophysiology, Medicinal Chemistry, Physical Pharmaceutics, Pharmacology, Pharmacognosy, Herbal Drug Technology, Biopharmaceutics, Pharmacokinetics, Pharmaceutical Biotechnology and Quality Assurance across even semesters II, IV, VI and VIII. It also provides details of supportive staff for the course and concludes by stating that the next presentation will cover outcomes for odd semesters and framing of continuous assessment and practical internal exams.
B. pharm. course outcomes According to PCI syllabus fir NBASnehalChakorkar
This document outlines the course outcomes for various subjects across semesters in the B. Pharm. (PCI, New Delhi) syllabus. It lists the key learning objectives for each subject in the even semesters, including anatomy, physiology, organic chemistry, biochemistry, pathophysiology, pharmacology, and quality assurance. The objectives cover understanding concepts, mechanisms, classifications, summaries and applications of knowledge. It also recognizes the supportive staff involved in the program delivery.
B. pharm. course outcomes Even semester dr. amit gangwal & ms. s. s. chakorkarSnehalChakorkar
This document outlines the course outcomes for various subjects across semesters II, IV, VI, and VIII of the B. Pharm. (PCI) syllabus at New Delhi. It lists the key learning objectives for each subject in point form. The subjects covered include Human Anatomy and Physiology, Pharmaceutical Organic Chemistry, Biochemistry, Pathophysiology, Medicinal Chemistry, Physical Pharmaceutics, Pharmacology, Pharmacognosy, Herbal Drug Technology, Biopharmaceutics, Pharmaceutical Biotechnology, Quality Assurance, Biostatistics, Social and Preventive Pharmacy, and Pharmacovigilance. For each subject, 3-5 high-level course outcomes are provided relating to understanding concepts, mechanisms
This document outlines the syllabus for the subject Biopharmaceutics and Pharmacokinetics at Dr. Babasaheb Ambedkar Marathwada University. The syllabus covers 14 sections that include topics such as absorption, distribution, metabolism, elimination of drugs, pharmacokinetic models, bioavailability and bioequivalence. Some key areas covered are factors affecting drug absorption, distribution and elimination processes in the body, pharmacokinetic parameters and concepts such as volume of distribution, clearance and half-life. Mathematical treatments of compartment models and methods to determine pharmacokinetic parameters are also included.
PREFACE
Over the last few decades, the application of chemometric techniques to
all fields in analytical chemistry and particularly to analytical chromatography
and spectrometry has increased dramatically. The modern state and the novel
application fields of chemometrics, as an interdisciplinary and promising area,
have been transferred to legacy to many incoming young and experienced
analysts.
Considering chemometrics as an unavoidable part of experimental
design and data interpretation in personal work, the idea of writing this
monograph, as helpful supplement to common knowledge of chemometrics in
analytical chemistry, has originated.
It has been about 35 years since the first chemometric handbooks were
printed. Nowadays, everybody has to acknowledge a huge significance in
analytical chemistry and many related disciplines. The chemometric concept in
the most of these books has been presented to the readers in a manner that does
not assume a very good background in statistics or matrix algebra. Today
handbooks that are being printed present a huge effort to explain and clarify the
state of the art in chemometrics, so they can be highly recommended to anyone
working in this field.
This monograph represents the modest contribution to the modern
aspects of chemometrics, especially underlining the most popular methods and
scopes stuffed with comprehensive and useful examples of their practical
applications in analytical chemistry. Such monograph could be figured as useful
reading to a wide range of analytical chemistry practitioners who are not new in
this field but who simply need to have some specific aspects of chemometrics
all along in their everyday practice. Such aspects of this intricate and complex
matter are herein described in detail and designed to be easily reached and
understood.
Theoretical basics are explained and supported by practical examples in
a style that makes the material accessible to a broad audience of analytical
chemists. After all, this monograph certainly has been derived from a long-term
practical and theoretical work in this field and experience that has been gathered
on that road.
The monograph covers 12 chemometric fields of interest divided into 5
main chapters. Every chapter can be studied separately since it has been written
as a stand-along piece of text. This way, the reader could study every chapter as
a unity. Each topic is supported by basic theory, followed by several
representative examples. Some information are repeated in different places with
similar or different purpose so this hopefully could help the reader to recall or
rethink a topic in a different way.
Dr Antonije Onjia
This document describes an analytical toxicology report on the analysis of chemicals that may have adverse health effects. It discusses:
1. Analytical toxicology involves applying analytical chemistry tools to qualitatively and quantitatively analyze chemicals that could harm living organisms. This can help diagnose and prevent poisoning.
2. Several factors must be considered before analysis, like the amount of sample available and which poison is suspected. Samples like GI contents, urine, liver and concentrated tissues are analyzed depending on the poison.
3. Modern techniques like GC-MS and LC-MS are commonly used to simultaneously separate and quantify analytes. This report presents a real case study where these methods were used to detect anticoagulant rodent
Integrating Ayurveda into Parkinson’s Management: A Holistic ApproachAyurveda ForAll
Explore the benefits of combining Ayurveda with conventional Parkinson's treatments. Learn how a holistic approach can manage symptoms, enhance well-being, and balance body energies. Discover the steps to safely integrate Ayurvedic practices into your Parkinson’s care plan, including expert guidance on diet, herbal remedies, and lifestyle modifications.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptx
Pharmacology (Proposed) Syllabus- Effective from the Session 2017-18 (2).pdf
1. DR. A.P.J
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2. Master of Pharmacy (M. Pharm.)
SCHEMES FOR INTERNAL ASSESSMENTS AND END SEMESTER EXAMINATIONS (SEM. I & II)
(W.E.F. Session 2017-18)
PHARMACOLOGY-MPL
Course
Code
Course Internal Assessment End Semester
Exams
Total
Marks
Credit
Points
Continu
ous
Mode
Sessional Exams Marks Duration
Marks Duration Total
Semester I
MPL101T
(New)
Modern
Pharmaceutical
Analytical Techniques
10 15 1 Hrs 25 75 3 Hrs 100 4
MPL102T
(New)
Advanced
Pharmacology-I
10 15 1 Hrs 25 75 3 Hrs 100 4
MPL103T
(New)
Pharmacological
and Toxicological
Screening Methods-I
10 15 1 Hrs 25 75 3 Hrs 100 4
MPL104T
(New)
Cellular and Molecular
Pharmacology
10 15 1 Hrs 25 75 3 Hrs 100 4
MPL105P
(New)
Experimental
Pharmacology - I
20 30 6 Hrs 50 100 6 Hrs 150 6
- Seminar/ Assignment - - - - - - 100 4
Total 650 26
Semester II
MPL201T
(New)
Advanced
Pharmacology II
10 15 1 Hr 25 75 3 Hrs 100 4
MPL202T
(New)
Pharmacological
and Toxicological
Screening Methods-II
10 15 1 Hr 25 75 3 Hrs 100 4
MPL203T
(New)
Principles of
Drug Discovery
10 15 1 Hr 25 75 3 Hrs 100 4
MPL204T
(New)
Clinical Research
and Pharmacovigilance
10 15 1 Hr 25 75 3 Hrs 100 4
MPL205P
(New)
Experimental
Pharmacology - II
20 30 6 Hrs 50 100 6 Hrs 150 6
- Seminar/Assignment - - - - - - 100 4
Total 650 26
3. Schemes for Internal Assessments and End Semester Examinations (Semester III & IV)
Course
Code
Course Internal Assessment End Semester
Exams
Total
Marks
Credit
Points
Contin
uous
Mode
Sessional Exams Total Marks Duration
Marks Duration
Semester III
MRM301T
(New)
Research
Methodology and
Biostatistics
40 60 2 Hr 100 - - 100 4
MRM302T
(New)
Journal Club - - - 25 - - 25 1
MRM303P
(New)
Discussion
/Presentation
(Proposal
Presentation)
- - - 50 - - 50 2
MRM304P
(New)
Research Work 350 - - - - - 350 14
Total 525 21
Semester IV
MRM401T
(New)
Journal Club - - - 25 - - 25 1
MRM402P
(New)
Discussion /
Presentation
(Proposal
Presentation)
- - - 75 - - 75 3
MRM403P
(New)
Research Work and
Colloquium
- - - - 400 1 Hr 400 16
Total 500 20
4. PHARMACOLOGY (MPL)
FIRST SEMESTER
MODERN PHARMACEUTICAL ANALYTICAL TECHNIQUES
(MPL 101T)
Scope
This subject deals with various advanced analytical instrumental techniques for identification,
characterization and quantification of drugs. Instruments dealt are NMR, Mass spectrometer, IR, HPLC,
GC etc.
Objectives
After completion of course student is able to know about,
• Chemicals and excipients.
• The analysis of various drugs in single and combination dosage forms.
• Theoretical and practical skills of the instruments.
THEORY 60 Hrs
1. UV-Visible spectroscopy: Introduction, theory, laws, and instrumentation associated with
UV-visible spectroscopy, choice of solvents and solvent effect. Applications of UV-Visible
spectroscopy. Difference/ derivative spectroscopy.
IR spectroscopy: Theory, modes of molecular vibrations, sample handling, instrumentation
of dispersive and Fourier–Transform IR spectrometer, factors affecting vibrational
frequencies. Applications of IR spectroscopy and data interpretation. Spectroflourimetry:
Theory of fluorescence, factors affecting fluorescence (characterestics of drugs that can be
analyzed by flourimetry), quenchers. Instrumentation and applications of fluorescence
spectrophotometer.
Flame Emission Spectroscopy and Atomic Absorption Spectroscopy: Principle,
instrumentation, interferences and applications.
10 Hrs
2. NMR spectroscopy: Quantum numbers and their role in NMR. Principle, instrumentation,
solvent requirement in NMR, relaxation process, NMR signals in various compounds.
Chemical shift, factors influencing chemical shift, spin-spin coupling, coupling constant,
nuclear magnetic double resonance. Brief outline of principles of FT-NMR and 13C NMR.
Applications of NMR spectroscopy.
10 Hrs
3. Mass Spectroscopy: Principle, Theory, Instrumentation of Mass Spectroscopy, Different
types of ionization like electron impact, chemical, field, FAB and MALDI, APCI, ESI,
APPI Analyzers of Quadrupole and Time of Flight, Mass fragmentation and its rules, Meta
stable ions, Isotopic peaks and Applications of Mass spectroscopy.
10 Hrs
1. Chromatography: Principle, apparatus, instrumentation, chromatographic parameters,
factors affecting resolution, isolation of drug from excipients, data interpretation and
applications of the following:
a) Thin layer chromatography.
b) High performance thin layer chromatography.
c) Ion exchange chromatography.
d) Column chromatography.
e) Gas chromatography.
10 Hrs
5. f) High performance liquid chromatography.
g) Ultra high performance liquid chromatography.
h) Affinity chromatography.
i) Gel chromatography.
2. Electrophoresis: Principle, instrumentation, working conditions, factors affecting
separation and applications of the following:
a) Paper electrophoresis.
b) Gel electrophoresis.
c) Capillary electrophoresis.
d) Zone electrophoresis.
e) Moving boundary electrophoresis.
f) Isoelectric focusing.
X ray Crystallography: Production of X rays, different X ray methods, Bragg‘s law,
rotating crystal technique, X ray powder technique, of crystals and applications of X-ray
diffraction.
10 Hrs
3. a. Potentiometry: Principle, working, Ion selective electrodes and application of
potentiometry.
b. Thermal Techniques: Principle, thermal transitions and instrumentation (Heat flux and
power-compensation and designs), modulated DSC, hyper DSC, experimental parameters
(sample preparation, experimental conditions, calibration, heating and cooling rates,
resolution, source of errors) and their influence, advantage and disadvantages,
pharmaceutical applications.
Differential Thermal Analysis (DTA): Principle, instrumentation and advantage and
disadvantages, pharmaceutical applications, derivative differential thermal analysis
(DDTA).
TGA: Principle, instrumentation, factors affecting results, advantage and disadvantages,
pharmaceutical applications.
c. Immunological Assays: RIA (Radio immune assay), ELISA, bioluminescence assays.
10 Hrs
REFERENCES
1. Spectrometric Identification of Organic compounds by Robert M Silverstein, Sixth edition, John Wiley
& Sons, 2004.
2. Principles of Instrumental Analysis by Douglas A Skoog, F. James Holler, Timothy A. Nieman, 5th
edition, Eastern press, Bangalore, 1998.
3. Instrumental Methods of Analysis by Willards, 7th edition, CBS Publishers.
4. Practical Pharmaceutical Chemistry by Beckett and Stenlake, Vol II, 4th
edition, CBS Publishers, New
Delhi, 1997.
5. Organic Spectroscopy by William Kemp, 3rd edition, ELBS, 1991.
6. Quantitative Analysis of Drugs in Pharmaceutical Formulation by P D Sethi, 3rd Edition, CBS
Publishers, New Delhi, 1997.
7. Pharmaceutical Analysis - Modern Methods – Part B by J W Munson, Vol 11, Marcel. Dekker Series
8. Spectroscopy of Organic Compounds, 2nd edn., P.S. Kalsi, Wiley Eastern Ltd., Delhi.
9. Textbook of Pharmaceutical Analysis by KA. Connors, 3rd Edition, John Wiley & Sons, 1982.
10. Introduction to Spectroscopy by Pavia D.L., Lampman G.M. and Kriz G.S., Harcourt College
Publishers, Philadelphia.
6. 11. Analytical Profile of Drug Substance (All volume) by Florey K., Academic Press, Elsevier,
Massachusetts.
12. Thin Layer Chromatography: A Laboratory Handbook, Stahl E., Springer, Berlin.
13. Undergraduate Instrumental Analysis, Obonson J.W.R., Marcel Dekker Inc, New York.
14. Absorption Spectroscopy of Organic Molecules by Parikh V.H., Addison-Wesley Publishing Co.,
London.
7. ADVANCED PHARMACOLOGY - I
(MPL 102T)
Scope
The subject is designed to strengthen the basic knowledge in the field of pharmacology and to impart
recent advances in the drugs used for the treatment of various diseases. In addition, this subject helps the
students to understand the concepts of drug action and mechanisms involved.
Objectives
Upon completion of the course the student shall be able to :
• Discuss the pathophysiology and pharmacotherapy of certain diseases
• Explain the mechanism of drug actions at cellular and molecular level
• Understand the adverse effects, contraindications and clinical uses of drugs used in treatment of
diseases.
THEORY 60 Hrs
1. General Pharmacology
a. Pharmacokinetics: The dynamics of drug absorption, distribution, biotransformation
and elimination. Concepts of linear and non-linear compartment models. Significance of
Protein binding.
b. Pharmacodynamics: Mechanism of drug action and the relationship between drug
concentration and effect. Receptors, structural and functional families of receptors,
quantitation of drug receptors interaction and elicited effects.
12 Hrs
2. Neurotransmission
a. General aspects and steps involved in neurotransmission.
b. Neurohumoral transmission in autonomic nervous system (Detailed study about
neurotransmitters- Adrenaline and Acetyl choline).
c. Neurohumoral transmission in central nervous system (Detailed study about
neurotransmitters- histamine, serotonin, dopamine, GABA, glutamate and glycine).
d. Non adrenergic non cholinergic transmission (NANC). Cotransmission.
Systemic Pharmacology: A detailed study on pathophysiology of diseases, mechanism
of action, pharmacology and toxicology of existing as well as novel drugs used in the
following systems-
Autonomic Pharmacology
Parasympathomimetics and lytics, sympathomimetics and lytics, agents affecting
neuromuscular junction.
12 Hrs
3. Central nervous System Pharmacology:
General and local anesthetics
Sedatives and hypnotics, drugs used to treat anxiety.
Depression, psychosis, mania, epilepsy, neurodegenerative diseases.
Narcotic and non-narcotic analgesics.
12 Hrs
4. Cardiovascular Pharmacology: Diuretics, antihypertensives, antiischemics, anti-
arrhythmics, drugs for heart failure and hyperlipidemia. Hematinics, coagulants ,
anticoagulants, fibrinolytics and antiplatelet Drugs
12 Hrs
5. Autocoid Pharmacology: The physiological and pathological role of histamine, 12 Hrs
8. serotonin, kinins prostaglandins opioid autocoids. Pharmacology of antihistamines, 5HT
antagonists.
REFEERENCES
1. Goodman and Gilman, The Pharmacological Basis of Therapeutics by Hardman J.G., Le L., Molinoss
P.B., Ruddon R.W. and Gil A.G., Pergamon Press, Oxford.
2. Principles of Pharmacology: The Pathophysiologic Basis of Drug Therapy by Golan D.E., Armstrong
E.J., Armstrong A.W., Wolters Kluwer, Alphen aan den Rijn.
3. Basic and Clinical Pharmacology by Katzung, B.G. Prentice Hall International, New Delhi.
4. Pharmacology by Rang M.P., Dale MM, Riter J.M, Churchill Livingstone, London.
5. Biopharmaceutics & Clinical Pharmacokinetics by Gibaldi, M., Pharma Book Syndicate, Hyderabad.
6. Clinical Pharmacy and Therapeutics by Herfindal E.T. and Hirashman J.L., Lippincott Williams and
Wilkins, Philadelphia.
7. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial
Scientists by Kwon Y., Springer, New York.
8. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.
9. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu.
10. Oxford Textbook of Clinical Pharmacology by Graham Smith.
11. Dipiro Pharmacology, Pathophysiological Approach.
9. PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS - I
(MPL 103T)
Scope
This subject is designed to impart the knowledge on preclinical evaluation of drugs and recent
experimental techniques in the drug discovery and development. The subject content helps the student
to understand the maintenance of laboratory animals as per the guidelines, basic knowledge of various
in-vitro and in-vivo preclinical evaluation processes.
Objectives
Upon completion of the course the student shall be able to,
• Appraise the regulations and ethical requirement for the usage of experimental animals.
• Describe the various animals used in the drug discovery process and good laboratory practices in
maintenance and handling of experimental animals.
• Describe the various newer screening methods involved in the drug discovery process.
• Appreciate and correlate the preclinical data to humans.
THEORY 60 Hrs
1. Laboratory Animals
Common laboratory animals: Description, handling and applications of different species
and strains of animals.
Transgenic animals: Production, maintenance and applications. Anaesthesia and
euthanasia of experimental animals. Maintenance and breeding of laboratory animals.
CPCSEA guidelines to conduct experiments on animals. Good laboratory practices.
Bioassay: Principle, scope and limitations and methods.
12 hrs
2. Preclinical screening of new substances for the pharmacological activity using in vivo,
in vitro, and other possible animal alternative models.
General principles of preclinical screening.
CNS Pharmacology: Behavioral and muscle coordination, CNS stimulants and
depressants, anxiolytics, anti-psychotics, anti epileptics and nootropics. Drugs for
neurodegenerative diseases like Parkinsonism, Alzheimers and multiple sclerosis. Drugs
acting on Autonomic Nervous System.
12 Hrs
3. Preclinical screening of new substances for the pharmacological activity using in vivo,
in vitro, and other possible animal alternative models.
Respiratory Pharmacology: anti-asthmatics, drugs for COPD and anti allergics.
Reproductive Pharmacology: Aphrodisiacs and anti-fertility agents.
Analgesics, anti-inflammatory and antipyretic agents.
Gastrointestinal drugs: anti ulcer, anti -emetic, anti-diarrheal and laxatives.
12 Hrs
4. Preclinical screening of new substances for the pharmacological activity using in vivo,
in vitro, and other possible animal alternative models.
Cardiovascular Pharmacology: antihypertensives, antiarrythmics, antianginal,
antiatherosclerotic agents and diuretics.
Drugs for metabolic disorders like anti-diabetic, antidyslipidemic agents.
Anti cancer agents.
Hepatoprotective screening methods.
12 Hrs
10. 5. Preclinical screening of new substances for the pharmacological activity using in vivo,
in vitro, and other possible animal alternative models.
Iimmunomodulators, Immunosuppressants and immunostimulants.
General principles of immunoassay: Theoretical basis and optimization of
immunoassay, heterogeneous and homogenous immunoassay systems. Immunoassay
methods evaluation; protocol outline, objectives and preparation. Immunoassay for
digoxin and insulin Limitations of animal experimentation and alternate animal
experiments. Extrapolation of in vitro data to preclinical and preclinical to humans.
12 Hrs
REFERENCES
1. Screening Methods in Pharmacology by Turner R.A., Hebborn P., Academic Press, Cambridge.
2. Evaluation of drugs activities by Laurence D.R., Bacharach A.L., Academic Press, Cambridge.
3. Methods in Pharmacology by Arnold S., Springer, New York.
4. Fundamentals of Experimental Pharmacology by Ghosh M.N. Scientific Book Agency, Calcutta.
5. Pharmacological Experiment on Intact Preparations by Mcleod, L.J., Churchill Livingstone, London.
6. Drug discovery and Evaluation by Vogel H.G., Springer-Verlag, Heidelberg.
7. Practicals in Pharmacology by Goyal R.K., B.S. Shah Prakashan, Ahmadabad.
8. Preclinical Evaluation of New Drugs by Gupta S.K., Jaypee Brothers Medical Publishers Private
Limited, New Delhi.
9. CPCSEA, OECD, ICH, USFDA, Schedule Y, EPA Guidelines.
10. Biological standardization by J.H. Burn D.J. Finney and I.G. Goodwin.
11. Handbook of Experimental Pharmacology, S.K..Kulkarni.
12. Practical Pharmacology and Clinical Pharmacy, S.K..Kulkarni, 3rd Edition.
13. David R.Gross. Animal Models in Cardiovascular Research, 2nd Edition, Kluwer Academic
Publishers, London, UK.
14. Screening Methods in Pharmacology, Robert A. Turner.
15. Rodents for Pharmacological Experiments, Tapan Kumar Chatterjee.
16. Practical Manual of Experimental and Clinical Pharmacology by Bikash Medhi (Author), Ajay
Prakash (Author).
11. CELLULAR AND MOLECULAR PHARMACOLOGY
(MPL 104T)
Scope
The subject imparts a fundamental knowledge on the structure and functions of cellular components and
help to understand the interaction of these components with drugs. This information will further help the
student to apply the knowledge in drug discovery process.
Objectives
• Upon completion of the course, the student shall be able to,
• Explain the receptor signal transduction processes.
• Explain the molecular pathways affected by drugs.
• Appreciate the applicability of molecular pharmacology and biomarkers in drug discovery
process.
• Demonstrate molecular biology techniques as applicable for pharmacology.
THEORY 60 Hrs
1. Cell Biology: Structure and functions of cell and its organelles Genome organization.
Gene expression and its regulation, importance of siRNA and micro RNA, gene mapping
and gene sequencing.
Cell cycles and its regulation.
Cell death– events, regulators, intrinsic and extrinsic pathways of apoptosis.
Necrosis and autophagy.
12 Hrs
2. Cell Signaling
Intercellular and intracellular signaling pathways.
Classification of receptor family and molecular structure ligand gated ion channels; G-
protein coupled receptors, tyrosine kinase receptors and nuclear receptors.
Secondary messengers: cyclic AMP, cyclic GMP, calcium ion, inositol 1,4,5-
trisphosphate, (IP3), NO, and diacylglycerol.
Detailed study of following intracellular signaling pathways: cyclic AMP signaling
pathway, mitogen-activated protein kinase (MAPK) signaling, Janus kinase (JAK)/signal
transducer and activator of transcription (STAT) signaling pathway.
12 Hrs
3. Principles and applications of genomic and proteomic tools DNA electrophoresis, PCR
(reverse transcription and real time), Gene sequencing, micro array technique, SDS page,
ELISA and western blotting, recombinant DNA technology and gene therapy.
Basic principles of recombinant DNA technology-Restriction enzymes, various types of
vectors. Applications of recombinant DNA technology.
Gene therapy- Various types of gene transfer techniques, clinical applications and recent
advances in gene therapy.
12 Hrs
12. 4. Pharmacogenomics
Gene mapping and cloning of disease gene.
Genetic variation and its role in health/ pharmacology.
Polymorphisms affecting drug metabolism.
Genetic variation in drug transporters.
Genetic variation in G protein coupled receptors.
Applications of proteomics science: Genomics, proteomics, metabolomics, functionomics,
nutrigenomics .
Immunotherapeutics.
Types of immunotherapeutics, humanisation antibody therapy, Immunotherapeutics in
clinical practice.
12 Hrs
5. a. Cell Culture Techniques: Basic equipments used in cell culture lab. Cell culture
media, various types of cell culture, general procedure for cell cultures: Isolation of cells,
subculture, cryopreservation, characterization of cells and their application. Principles and
applications of cell viability assays, glucose uptake assay, calcium influx assays.
Principles and applications of flow cytometry.
b. Biosimilars
12 Hrs
REFERENCES:
1. The Cell, A Molecular Approach. Geoffrey M Cooper, Sinauer Publisher, USA.
2. Pharmacogenomics: The Search for Individualized Therapies. Edited by J. Licinio and M -L. Wong,
Wiley-VCH, Weinheim.
3. Handbook of Cell Signaling by Bradshaw R.A., Denis E.A., Academic Press, Cambridge (Second
Edition) Edited by Ralph A. et.al.
4. Molecular Pharmacology: From DNA to Drug Discovery. John Dickenson et.al., Wiley, Colorado.
5. Basic Cell Culture protocols by Cheril D.Helgason and Cindy L.Miller, Springer, New York.
6. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor), Oxford University Press, Oxford
7. Animal Cell Culture: A Practical Approach by John R. Masters (Editor), Oxford University Press,
Oxford.
8. Current porotocols in molecular biology vol I to VI edited by Frederick M.Ausuvel et al., Wiley, New
Jersey.
13. PHARMACOLOGICAL PRACTICAL - I
(MPL 105P)
1. Analysis of Pharmacopoeial compounds and their formulations by UV Vis spectrophotometer.
2. Simultaneous estimation of multi component containing formulations by UV spectrophotometry.
3. Experiments based on HPLC.
4. Experiments based on gas chromatography.
5. Estimation of riboflavin/quinine sulphate by fluorimetry.
6. Estimation of sodium/potassium by flame photometry.
Handling of laboratory animals:
1. Various routes of drug administration.
2. Techniques of blood sampling, anesthesia and euthanasia of experimental animals.
3. Functional observation battery tests (modified Irwin test).
4. Evaluation of CNS stimulant, depressant, anxiogenics and anxiolytic, anticonvulsant activity.
5. Evaluation of analgesic, anti-inflammatory, local anesthetic, mydriatic and miotic activity.
6. Evaluation of diuretic activity.
7. Evaluation of antiulcer activity by pylorus ligation method.
8. Oral glucose tolerance test.
9. Isolation and identification of DNA from various sources (Bacteria, cauliflower, onion, goat liver).
10. Isolation of RNA from yeast.
11. Estimation of proteins by Braford/Lowry’s in biological samples.
12. Estimation of RNA/DNA by UV Spectroscopy.
13. Gene amplification by PCR.
14. Protein quantification Western Blotting.
15. Enzyme based in-vitro assays (MPO, AChEs, α amylase, α glucosidase).
16. Cell viability assays (MTT/Trypan blue/SRB).
17. DNA fragmentation assay by agarose gel electrophoresis.
18. DNA damage study by Comet assay.
19. Apoptosis determination by fluorescent imaging studies.
20. Pharmacokinetic studies and data analysis of drugs given by different routes of administration
using softwares.
21. Enzyme inhibition and induction activity.
22. Extraction of drug from various biological samples and estimation of drugs in biological fluids
using different analytical techniques (UV).
23. Extraction of drug from various biological samples and estimation of drugs in biological fluids
using different analytical techniques (HPLC).
14. REFERENCES
1. CPCSEA, OECD, ICH, USFDA, Schedule Y, EPA guidelines.
2. Fundamentals of experimental Pharmacology by M.N.Ghosh.
3. Handbook of Experimental Pharmacology by S.K. Kulkarni.
4. Drug discovery and Evaluation by Vogel H.G.
5. Spectrometric Identification of Organic compounds - Robert M Silverstein.
6. Principles of Instrumental Analysis - Doglas A Skoog, F. James Holler, Timothy A. Nieman.
7. Vogel‘s Text book of quantitative chemical analysis - Jeffery, Basset, Mendham, Denney.
8. Basic Cell Culture protocols by Cheril D. Helgason and Cindy L. Mille.
9. Basic Cell Culture (Practical Approach ) by J. M. Davis (Editor).
10. Animal Cell Culture: A Practical Approach by John R. Masters (Editor).
11. Practical Manual of Experimental and Clinical Pharmacology by Bikash Medhi (Author), Ajay Prakash
(Author) Jaypee Brothers’ Medical Publishers Pvt. Ltd.
15. SECOND SEMESTER
ADVANCED PHARMACOLOGY - II
(MPL 201T)
Scope
The subject is designed to strengthen the basic knowledge in the field of pharmacology and to impart
recent advances in the drugs used for the treatment of various diseases. In addition, the subject helps the
student to understand the concepts of drug action and mechanism involved.
Objectives
Upon completion of the course the student shall be able to:
• Explain the mechanism of drug actions at cellular and molecular level.
• Discuss the pathophysiology and pharmacotherapy of certain diseases.
• Understand the adverse effects, contraindications and clinical uses of drugs used in treatment of
diseases.
THEORY 60 Hrs
1. Endocrine Pharmacology: Molecular and cellular mechanism of action of hormones such
asgrowth hormone, prolactin, thyroid, insulin and sex hormones, anti-thyroid drugs, oral
hypoglycemic agents, oral contraceptives, corticosteroids. Drugs affecting calcium
regulation.
12 Hrs
2. Chemotherapy: Cellular and molecular mechanism of actions and resistance of
antimicrobial agents such as ß-lactams, aminoglycosides, quinolones, macrolide antibiotics.
Antifungal, antiviral, and anti-TB drugs.
12 Hrs
3. Chemotherapy:
Drugs used in protozoal infections
Drugs used in the treatment of helminthiasis
Chemotherapy of cancer
Immunopharmacology
Cellular and biochemical mediators of inflammation and immune response. Allergic or
hypersensitivity reactions. Pharmacotherapy of asthma and COPD.
Immunosuppressants and immunostimulants
12 Hrs
4. GIT Pharmacology:
Antiulcer drugs, prokinetics, antiemetics, anti-diarrheals and drugs for constipation and
irritable bowel syndrome.
Chronopharmacology
Biological and circadian rhythms, applications of chronotherapy in various diseases like
cardiovascular disease, diabetes, asthma and peptic ulcer.
12 Hrs
5. Free Radicals Pharmacology: Generation of free radicals, role of free radicals in
etiopathology of various diseases such as diabetes, neurodegenerative diseases and cancer.
Protective activity of certain important antioxidant
Recent Advances in Treatment: Alzheimer’s disease, Parkinson’s disease, Cancer,
Diabetes Mellitus.
12 Hrs
16. REFERENCES
1. Goodman and Gill man's-The Pharmacological Basis of Therapeutics- by Hardman J.G., Limbird
Le, Molinoss P.B., Ruddon R.W. and Gil A.G.,
2. Principles of Pharmacology. The Pathophysiologic Basis of Drug Therapy by David E Golan et al.,
Wolters Kluwer, Alphen aan den Rijn.
3. Basic and Clinical Pharmacology by B.G –Katzung, Prentice Hall International, New Jersey.
4. Pharmacology by H.P. Rang and M.M. Dale, Churchill Livingstone, London.
5. Hand book of Clinical Pharmacokinetics by Gibaldi and Prescott.
6. Text book of Therapeutics, Drug and Disease Management by E T. Herfindal and Gourley,
Williams and Wilkins, Philadelphia.
7. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu.
8. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for Industrial
Scientists.
9. Robbins & Cortan Pathologic Basis of Disease, 9th Ed. (Robbins Pathology).
10. A Complete Textbook of Medical Pharmacology by Dr. S.K Srivastava published by APC Avichal
Publishing Company.
11. Essentials of Medical Pharmacology, K.D.Tripathi.
12. Principles of Pharmacology. The Pathophysiologic Basis of Drug Therapy by David E Golan,
Armen H, Tashjian Jr, Ehrin J,Armstrong, April W, Armstrong, Wolters, Kluwer-Lippincott
Williams & Wilkins Publishers.
17. PHARMACOLOGICAL AND TOXICOLOGICAL SCREENING METHODS-II
(MPL 202T)
Scope
This subject imparts knowledge on the preclinical safety and toxicological evaluation of drug & new
chemical entity. This knowledge will make the student competent in regulatory toxicological evaluation.
Objectives
Upon completion of the course, the student shall be able to,
• Explain the various types of toxicity studies.
• Appreciate the importance of ethical and regulatory requirements for toxicity studies.
• Demonstrate the practical skills required to conduct the preclinical toxicity studies.
THEORY 60 Hrs
1. Basic definition and types of toxicology (general, mechanistic, regulatory and descriptive)
Regulatory guidelines for conducting toxicity studies OECD, ICH, EPA and Schedule Y
OECD principles of Good laboratory practice (GLP).
History, concept and its importance in drug development.
12 Hrs
2. Acute, sub-acute and chronic- oral, dermal and inhalational studies as per OECD
guidelines.
Acute eye irritation, skin sensitization, dermal irritation & dermal toxicity studies.
Test item characterization- importance and methods in regulatory toxicology studies.
12 Hrs
3. Reproductive toxicology studies, male reproductive toxicity studies, female reproductive
studies (segment I and segment III), teratogenecity studies (segment II)
Genotoxicity studies (Ames test, in vitro and in vivo micronucleus and chromosomal
aberrations studies). In vivo carcinogenicity studies.
12 Hrs
4. IND enabling studies (IND studies)- Definition of IND, importance of IND, industry
perspective, list of studies needed for IND submission.
Safety pharmacology studies- Origin, concepts and importance of safety pharmacology.
Tier1- CVS, CNS and respiratory safety pharmacology, HERG assay. Tier2- GI, renal
and other studies.
12 Hrs
5. Toxicokinetics- Toxicokinetic evaluation in preclinical studies, saturation kinetics.
Importance and applications of toxicokinetic studies.
Alternative methods to animal toxicity testing.
12 Hrs
REFERENCES
1. Hand book on GLP, Quality practices for regulated non-clinical research and development
(http://www.who.int/tdr/publications/documents/glphandbook.pdf).
2. Schedule Y Guideline: drugs and cosmetics (second amendment) rules, 2005, ministry of health and
family welfare (department of health) New Delhi
3. Drugs from discovery to approval by Rick NG.
4. Animal Models in Toxicology, 3rd Edition, Lower and Bryan
5. OECD test guidelines.
6. Principles of toxicology by Karen E. Stine, Thomas M. Brown.
7. Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and
Marketing Authorization for Pharmaceuticals.
19. PRINCIPLES OF DRUG DISCOVERY
(MPL 203T)
Scope
The subject imparts basic knowledge of drug discovery process. This information will make the student
competent in drug discovery process.
Objectives
Upon completion of the course, the student shall be able to,
• Explain the various stages of drug discovery.
• Appreciate the importance of the role of genomics, proteomics and bioinformatics in drug
discovery.
• Explain various targets for drug discovery.
• Explain various lead seeking method and lead optimization.
• Appreciate the importance of the role of computer aided drug design in drug discovery.
THEORY 60 Hrs
1. An Overview of Modern Drug Discovery Process: Target identification, target
validation, lead identification and lead optimization. Economics of drug discovery. Target
discovery and validation-Role of genomics, proteomics and bioinformatics. Role of
nucleic acid microarrays, protein microarrays, antisense technologies, siRNAs, antisense
oligonucleotides, zinc finger proteins. Role of transgenic animals in target validation.
12 Hrs
2. Lead Identification: combinatorial chemistry & high throughput screening, in silico lead
discovery techniques. Assay development for hit identification.
Protein structure: Levels of protein structure, domains, motifs, and folds in protein
structure. Computational prediction of protein structure: Threading and homology
modeling methods. Application of NMR and X-ray crystallography in protein structure
prediction.
12 Hrs
3. Rational Drug Design: Traditional vs rational drug design, methods followed in
traditional drug design, high throughput screening. Concepts of rational drug design.
Rational drug design methods: Structure and pharmacophore based approaches. Virtual
Screening techniques: Drug likeness screening, concept of pharmacophore mapping and
pharmacophore based screening.
12 Hrs
4. Molecular Docking: Rigid docking, flexible docking, manual docking: Docking based
screening. De novo drug design. Quantitative analysis of structure activity relationship:
History and development of QSAR, SAR versus QSAR, physicochemical parameters,
Hansch analysis, Fee-Wilson analysis and relationship between them.
12 Hrs
5. QSAR Statistical Methods: Regression analysis, partial least square analysis (PLS) and
other multivariate statistical methods. 3D-QSAR approaches like COMFA and COMSIA.
Prodrug design: Basic concept, prodrugs to improve patient acceptability, drug solubility,
drug absorption and distribution, site specific drug delivery and sustained drug action.
Rationale of prodrug design and practical consideration of prodrug design.
12 Hrs
REFERENCES
20. 1. Mouldy Sioud. Target Discovery and Validation Reviews and Protocols: Volume 2 Emerging
Molecular Targetsand Treatment Options. 2007 Humana Press Inc.
2. Darryl León. Scott MarkelIn. Silico Technologies in Drug Target Identification and Validation.
2006 by Taylor and Francis Group, LLC.
3. Johanna K. DiStefano. Disease Gene Identification. Methods and Protocols. Springer New York
Dordrecht Heidelberg London.
4. Hugo Kubiny. QSAR: Hansch Analysis and Related Approaches. Methods and Principles in
Medicinal Chemistry. Publisher Wiley-VCH.
5. Klaus Gubernator, Hans-Joachim Böhm. Structure-Based Ligand Design. Methods and Principles in
Medicinal Chemistry. Publisher Wiley-VCH.
6. Abby L. Parrill. M. Rami Reddy. Rational Drug Design. Novel Methodology and Practical
Applications. ACS Symposium Series; American Chemical Society: Washington, DC, 1999.
7. J. Rick Turner. New drug development design methodology and analysis. John Wiley & Sons, Inc.,
New Jersey.
21. CLINICAL RESEARCH AND PHARMACOVIGILANCE
(MPL 204T)
Scope
This subject will provide a value addition and current requirement for the students in clinical research and
pharmacovigilance. It will teach the students on conceptualizing, designing, conducting, managing and
reporting of clinical trials. This subject also focuses on global scenario of pharmacovigilance in different
methods that can be used to generate safety data. It will teach the students in developing drug safety data in
pre-clinical, clinical phases of drug development and post market surveillance.
Objectives
Upon completion of the course, the student shall be able to,
• Explain the regulatory requirements for conducting clinical trial.
• Demonstrate the types of clinical trial designs.
• Explain the responsibilities of key players involved in clinical trials.
• Execute safety monitoring, reporting and close-out activities.
• Explain the principles of pharmacovigilance.
• Detect new adverse drug reactions and their assessment.
• Perform the adverse drug reaction reporting systems and communication in pharmacovigilance.
THEORY 60 Hrs
1. Regulatory Perspectives of Clinical Trials: Origin and principles of international
conference on harmonization - Good clinical practice (ICH-GCP) guidelines. Ethical
Committee: Institutional review board, Ethical guidelines for biomedical research and
human participant- Schedule Y, ICMR informed consent process: Structure and content
of an informed consent process ethical principles governing informed consent process.
12 Hrs
2. Clinical Trials: Types and design experimental study- RCT and non RCT, observation
study: Cohort, case control, cross sectional clinical trial study team roles and
responsibilities of clinical trial personnel: Investigator, study coordinator, sponsor,
contract research organization and its management
12 Hrs
3. Clinical Trial Documentation: Guidelines to the preparation of documents, preparation
of protocol, investigator brochure, case report forms, clinical study report. Clinical trial
monitoring: Safety monitoring in CT. Adverse drug reactions: Definition and types,
detection and reporting methods. Severity and seriousness assessment. Predictability and
preventability assessment, management of adverse drug reactions: Terminologies of
ADR.
12 Hrs
4. Basic Aspects, Terminologies and Establishment of Pharmacovigilance: History and
progress of pharmacovigilance, significance of safety monitoring, pharmacovigilance in
India and international aspects, WHO international drug monitoring programme, WHO
and regulatory terminologies of ADR, evaluation of medication safety, establishing
pharmacovigilance centers in hospitals, industry and national programmes related to
pharmacovigilance. Roles and responsibilities in pharmacovigilance.
12 Hrs
22. 5. Methods, ADR reporting and tools used in pharmacovigilance international classification
of diseases, international nonproprietary names for drugs, passive and active
surveillance, comparative observational studies, targeted clinical investigations and
vaccine safety surveillance. Spontaneous reporting system and reporting to regulatory
authorities, guidelines for ADRs reporting. Argus, Aris G pharmacovigilance, VigiFlow,
statistical methods for evaluating medication safety data.
12 Hrs
6. Pharmacoepidemiology, pharmacoeconomics, safety pharmacology. 12 Hrs
REFERENCES
1. Central Drugs Standard Control Organization- Good Clinical Practices, Guidelines for Clinical
Trials on Pharmaceutical Products in India. New Delhi: Ministry of Health;2001.
2. International Conference on Harmonization of Technical requirements for registration of
Pharmaceuticals for human use. ICH Harmonized Tripartite Guideline. Guideline for Good
Clinical Practice.E6; May 1996.
3. Ethical Guidelines for Biomedical Research on Human Subjects 2000. Indian Council of
Medical Research, New Delhi.
4. Textbook of Clinical Trials edited by David Machin, Simon Day and Sylvan Green, March
2005, John Wiley and Sons.
5. Clinical Data Management edited by R K Rondels, S A Varley, C F Webbs. Second Edition,
Jan 2000, Wiley Publications.
6. Handbook of clinical Research. Julia Lloyd and Ann Raven Ed. Churchill Livingstone.
7. Principles of Clinical Research edited by Giovanna di Ignazio, Di Giovanna and Haynes.
23. PHARMACOLOGICAL PRACTICAL - II
(MPL 205P)
1. To record the DRC of agonist using suitable isolated tissues preparation.
2. To study the effects of antagonist/potentiating agents on DRC of agonist using suitable isolated
tissue preparation.
3. To determine to the strength of unknown sample by matching bioassay by using suitable tissue
preparation.
4. To determine to the strength of unknown sample by interpolation bioassay by using suitable
tissue preparation.
5. To determine to the strength of unknown sample by bracketing bioassay by using suitable tissue
preparation.
6. To determine to the strength of unknown sample by multiple point bioassay by using suitable
tissue preparation.
7. Estimation of PA2 values of various antagonists using suitable isolated tissue preparations.
8. To study the effects of various drugs on isolated heart preparations
9. Recording of rat BP, heart rate and ECG.
10. Recording of rat ECG.
11. Drug absorption studies by averted rat ileum preparation.
12. Acute oral toxicity studies as per OECD guidelines.
13. Acute dermal toxicity studies as per OECD guidelines.
14. Repeated dose toxicity studies- Serum biochemical, haematological, urine analysis, functional
observation tests and histological studies.
15. Drug mutagenicity study using mice bone-marrow chromosomal aberration test.
16. Protocol design for clinical trial (3 Nos.).
17. Design of ADR monitoring protocol.
18. In-silico docking studies (2 Nos.).
19. In-silico pharmacophore based screening.
20. In-silico QSAR studies.
21. ADR reporting.
REFERENCES
1. Fundamentals of experimental Pharmacology -by M.N. Ghosh
2. Hand book of Experimental Pharmacology- S.K. Kulakarni
3. Text book of in-vitro practical Pharmacology by Ian Kitchen
4. Bioassay Techniques for Drug Development by Atta-ur-Rahman, Iqbal choudhary and William
Thomsen.
5. Applied biopharmaceutics and Pharmacokinetics by Leon Shargel and Andrew B.C.Yu.
6. Handbook of Essential Pharmacokinetics, Pharmacodynamics and Drug Metabolism for
Industrial Scientists.