This course, Applied Clinical Biochemistry- II, is designed to impart in-depth knowledge about the techniques and methods used in clinical biochemistry. The curriculum focuses on automation in clinical biochemistry, methods of estimation and assessment, enzyme principles and estimation, gastric analysis, renal function tests, qualitative tests, and chemical examination. The students will engage in practical applications of these concepts through hands-on experimentation.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
The syllabus focuses on providing students with a comprehensive understanding of the hematology laboratory, including its role in healthcare, essential techniques used in hematological testing, advanced hematology techniques for diagnosing disorders, and quality control procedures and troubleshooting in the lab.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course in Haematology equips students with a comprehensive understanding of blood, its cellular components, laboratory safety measures, hematological studies, and quality assurance in the field of Haematology. The course includes a theoretical exploration of various aspects of Haematology, as well as practical experiments to provide hands-on experience.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This syllabus for "Applied Haematology-I" aims to equip students with comprehensive knowledge and practical skills concerning the essential aspects of haematology, including blood component estimation, staining techniques, understanding physiological variations, body fluid examination, and coagulation studies. It is designed to provide students with a deep understanding of theoretical concepts and their practical applications, which are crucial for a career in medical laboratory technology.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This syllabus of Medical Parasitology and Entomology aims to equip students with the understanding of medically important parasites. This includes their general characteristics, life cycle, and laboratory diagnosis. The students will also learn different diagnostic procedures including stool examination, blood examination, and specialized diagnostic techniques for various parasites. Practical experiments are an integral part of this syllabus, enhancing the students' understanding and skills.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
16_Program Elective course - I (Good lab practies).pdfVamsi kumar
This course "Good Laboratory Practices" will guide the students through the basics of good lab practices, ensuring safety and risk management, delve deeper into quality control and assurance, and finally explore the implementation of these practices in specialized areas like clinical, diagnostic, and research labs. The syllabus will provide a deep understanding of laboratory standard operating procedures, quality improvement cycles, the role of proficiency testing, and the ethical considerations involved in lab practices. Through a series of case studies, students will also be exposed to practical, real-world scenarios where they can apply their theoretical knowledge.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course, Applied Clinical Biochemistry- II, is designed to impart in-depth knowledge about the techniques and methods used in clinical biochemistry. The curriculum focuses on automation in clinical biochemistry, methods of estimation and assessment, enzyme principles and estimation, gastric analysis, renal function tests, qualitative tests, and chemical examination. The students will engage in practical applications of these concepts through hands-on experimentation.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
The syllabus focuses on providing students with a comprehensive understanding of the hematology laboratory, including its role in healthcare, essential techniques used in hematological testing, advanced hematology techniques for diagnosing disorders, and quality control procedures and troubleshooting in the lab.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course in Haematology equips students with a comprehensive understanding of blood, its cellular components, laboratory safety measures, hematological studies, and quality assurance in the field of Haematology. The course includes a theoretical exploration of various aspects of Haematology, as well as practical experiments to provide hands-on experience.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This syllabus for "Applied Haematology-I" aims to equip students with comprehensive knowledge and practical skills concerning the essential aspects of haematology, including blood component estimation, staining techniques, understanding physiological variations, body fluid examination, and coagulation studies. It is designed to provide students with a deep understanding of theoretical concepts and their practical applications, which are crucial for a career in medical laboratory technology.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This syllabus of Medical Parasitology and Entomology aims to equip students with the understanding of medically important parasites. This includes their general characteristics, life cycle, and laboratory diagnosis. The students will also learn different diagnostic procedures including stool examination, blood examination, and specialized diagnostic techniques for various parasites. Practical experiments are an integral part of this syllabus, enhancing the students' understanding and skills.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
16_Program Elective course - I (Good lab practies).pdfVamsi kumar
This course "Good Laboratory Practices" will guide the students through the basics of good lab practices, ensuring safety and risk management, delve deeper into quality control and assurance, and finally explore the implementation of these practices in specialized areas like clinical, diagnostic, and research labs. The syllabus will provide a deep understanding of laboratory standard operating procedures, quality improvement cycles, the role of proficiency testing, and the ethical considerations involved in lab practices. Through a series of case studies, students will also be exposed to practical, real-world scenarios where they can apply their theoretical knowledge.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course offers Medical Lab Technology students a comprehensive insight into Clinical Pathology and Histopathology through a series of visits to these laboratories. Through structured units, students will gain foundational knowledge, observe advanced techniques, and explore emerging trends in these fields. They will also apply their knowledge through a series of relevant case studies.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course provides an in-depth exploration of blood bank laboratory practices and procedures, introducing students to the core concepts and technical skills involved in blood banking. The program uses a case-based approach to facilitate the application of theoretical knowledge to practical scenarios, encouraging problem-solving skills and clinical reasoning. The curriculum spans from basic principles and safety considerations to advanced testing techniques and current trends in blood banking, providing comprehensive coverage of this essential area of medical lab technology.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This syllabus provides a comprehensive overview of biochemistry laboratory practices for Medical Lab Technology students. It covers fundamental and advanced lab techniques, interpretation of biochemical analysis, an introduction to emerging technologies, and emphasizes ethical considerations in the lab setting. The curriculum aims to develop both technical proficiency and ethical awareness in future lab professionals.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course provides an overview of the fundamental principles of management, with a specific focus on their application in Medical Laboratory Science (MLS). Students will gain a thorough understanding of the ethical practices necessary for a clinical laboratory professional, the Good Laboratory Practice (GLP) Regulations and Accreditation, safety in a clinical laboratory, and quality management systems. The course also introduces the role of information systems in laboratory management and the ethical considerations in MLS practice. The course includes practical application of the concepts, ensuring students gain hands-on experience and skills.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
20_Basics of Haematological diseases.pdfVamsi kumar
This syllabus covers the fundamental understanding of Hematological diseases. It's divided into three main units: the first unit delves into Anemia and Morphologic Alterations in Neutrophils, the second unit covers Bleeding Disorders and Thrombosis, and the third unit is about Monitoring of Anticoagulants with emphasis on Oral Anticoagulants and Heparin. It also includes practical experiments for each unit.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
43_Program Elective course - III (Community medicine).pdfVamsi kumar
This syllabus covers the principles and applications of Community Medicine and Epidemiology. Students will gain a comprehensive understanding of community health, disease control, health promotion, and the role of medical social work. They will apply knowledge to real-world case studies, fostering skills in critical analysis, problem-solving, and ethical decision-making.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course in Analytical Clinical Biochemistry aims to provide students with a deep understanding of the principles, procedures, and techniques commonly used in the field. It covers spectrophotometry, colorimetry, photometry, various types of chromatography, and electrophoresis. Practical hands-on laboratory work complements the theoretical knowledge gained, enhancing students' comprehension and ability to apply these techniques.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This Medical Lab Technology Internship syllabus is intended to provide students with the opportunity to apply and enhance their knowledge and skills in the context of real-world laboratory settings. Over the course of six months, interns will gain hands-on experience in essential and advanced laboratory techniques, laboratory safety practices, quality assurance processes, and professional and ethical considerations in the field. Through practical learning and critical examination of case studies, students will emerge better prepared for their careers as Medical Lab Technologists.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
A Review on Step-by-Step Analytical Method Validationiosrphr_editor
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
This course is designed to provide students with a comprehensive understanding of the legal and ethical considerations integral to medical practice. It introduces learners to the foundations of medical law and ethics, explores the principles of medical ethics, and highlights the role of medical laws in patient care. The course also navigates the realm of patient rights and responsibilities and delves into the contemporary issues arising from technological advancements in healthcare. By examining a variety of case studies, students will gain real-world insights into these topics and be able to apply ethical and legal principles effectively in their professional practice.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course aims to provide a comprehensive understanding of the field of Cytopathology. It begins with the basics of cryostat sectioning and enzyme cytochemistry, proceeding towards an in-depth study of cytological investigations, including vital staining and aspiration cytology. The course then focuses on advanced topics like exfoliative cytology, automation in cytology, liquid-based cytology, and immune-cytochemistry. Finally, it allows students to apply their theoretical knowledge to practical applications and master various techniques and staining methods used in a Cytology lab.
This Advanced Haematology course focuses on various anemia types, Leukemia, hematological disorders, chromosomal studies related to these disorders, and the use of radioisotopes in haematology. The course also addresses the importance of safety measures regarding radiation hazards and the disposal of radioactive materials.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
The Clinical Visit course for Medical Lab Technology students is designed to offer a comprehensive understanding of clinical laboratories. The course is organized into three units, providing knowledge about the healthcare system, regulations, clinical lab techniques, roles of lab technologists, and the significance of lab reports. Each unit is enriched with case studies to support practical, experiential learning and foster critical thinking. The course aims to prepare students to effectively function in a clinical lab setting, promoting professional development and competency in medical lab technology.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course offers an integrated examination of the major metabolic pathways in our bodies, focusing on carbohydrates, proteins, lipids, nucleic acids, and enzymes. It provides a comprehensive overview of the digestion, absorption, and metabolism of these biomolecules, along with an understanding of related disorders. The practical aspect of the course is designed to strengthen the theoretical knowledge through various biochemical experiments.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
This course offers Medical Lab Technology students a comprehensive insight into Clinical Pathology and Histopathology through a series of visits to these laboratories. Through structured units, students will gain foundational knowledge, observe advanced techniques, and explore emerging trends in these fields. They will also apply their knowledge through a series of relevant case studies.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course provides an in-depth exploration of blood bank laboratory practices and procedures, introducing students to the core concepts and technical skills involved in blood banking. The program uses a case-based approach to facilitate the application of theoretical knowledge to practical scenarios, encouraging problem-solving skills and clinical reasoning. The curriculum spans from basic principles and safety considerations to advanced testing techniques and current trends in blood banking, providing comprehensive coverage of this essential area of medical lab technology.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This syllabus provides a comprehensive overview of biochemistry laboratory practices for Medical Lab Technology students. It covers fundamental and advanced lab techniques, interpretation of biochemical analysis, an introduction to emerging technologies, and emphasizes ethical considerations in the lab setting. The curriculum aims to develop both technical proficiency and ethical awareness in future lab professionals.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course provides an overview of the fundamental principles of management, with a specific focus on their application in Medical Laboratory Science (MLS). Students will gain a thorough understanding of the ethical practices necessary for a clinical laboratory professional, the Good Laboratory Practice (GLP) Regulations and Accreditation, safety in a clinical laboratory, and quality management systems. The course also introduces the role of information systems in laboratory management and the ethical considerations in MLS practice. The course includes practical application of the concepts, ensuring students gain hands-on experience and skills.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
20_Basics of Haematological diseases.pdfVamsi kumar
This syllabus covers the fundamental understanding of Hematological diseases. It's divided into three main units: the first unit delves into Anemia and Morphologic Alterations in Neutrophils, the second unit covers Bleeding Disorders and Thrombosis, and the third unit is about Monitoring of Anticoagulants with emphasis on Oral Anticoagulants and Heparin. It also includes practical experiments for each unit.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
43_Program Elective course - III (Community medicine).pdfVamsi kumar
This syllabus covers the principles and applications of Community Medicine and Epidemiology. Students will gain a comprehensive understanding of community health, disease control, health promotion, and the role of medical social work. They will apply knowledge to real-world case studies, fostering skills in critical analysis, problem-solving, and ethical decision-making.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course in Analytical Clinical Biochemistry aims to provide students with a deep understanding of the principles, procedures, and techniques commonly used in the field. It covers spectrophotometry, colorimetry, photometry, various types of chromatography, and electrophoresis. Practical hands-on laboratory work complements the theoretical knowledge gained, enhancing students' comprehension and ability to apply these techniques.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This Medical Lab Technology Internship syllabus is intended to provide students with the opportunity to apply and enhance their knowledge and skills in the context of real-world laboratory settings. Over the course of six months, interns will gain hands-on experience in essential and advanced laboratory techniques, laboratory safety practices, quality assurance processes, and professional and ethical considerations in the field. Through practical learning and critical examination of case studies, students will emerge better prepared for their careers as Medical Lab Technologists.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
A Review on Step-by-Step Analytical Method Validationiosrphr_editor
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
This course is designed to provide students with a comprehensive understanding of the legal and ethical considerations integral to medical practice. It introduces learners to the foundations of medical law and ethics, explores the principles of medical ethics, and highlights the role of medical laws in patient care. The course also navigates the realm of patient rights and responsibilities and delves into the contemporary issues arising from technological advancements in healthcare. By examining a variety of case studies, students will gain real-world insights into these topics and be able to apply ethical and legal principles effectively in their professional practice.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course aims to provide a comprehensive understanding of the field of Cytopathology. It begins with the basics of cryostat sectioning and enzyme cytochemistry, proceeding towards an in-depth study of cytological investigations, including vital staining and aspiration cytology. The course then focuses on advanced topics like exfoliative cytology, automation in cytology, liquid-based cytology, and immune-cytochemistry. Finally, it allows students to apply their theoretical knowledge to practical applications and master various techniques and staining methods used in a Cytology lab.
This Advanced Haematology course focuses on various anemia types, Leukemia, hematological disorders, chromosomal studies related to these disorders, and the use of radioisotopes in haematology. The course also addresses the importance of safety measures regarding radiation hazards and the disposal of radioactive materials.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
The Clinical Visit course for Medical Lab Technology students is designed to offer a comprehensive understanding of clinical laboratories. The course is organized into three units, providing knowledge about the healthcare system, regulations, clinical lab techniques, roles of lab technologists, and the significance of lab reports. Each unit is enriched with case studies to support practical, experiential learning and foster critical thinking. The course aims to prepare students to effectively function in a clinical lab setting, promoting professional development and competency in medical lab technology.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
This course offers an integrated examination of the major metabolic pathways in our bodies, focusing on carbohydrates, proteins, lipids, nucleic acids, and enzymes. It provides a comprehensive overview of the digestion, absorption, and metabolism of these biomolecules, along with an understanding of related disorders. The practical aspect of the course is designed to strengthen the theoretical knowledge through various biochemical experiments.
Created by: Mr. Attuluri Vamsi Kumar, Assistant Professor, Department of MLT, UIAHS, Chandigarh University, Mohali, Punjab. For more details website: https://www.mltmaster.com
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
Similar to introductiontoclinicalchemistry-150421021353-conversion-gate01.pdf (20)
Delivering Micro-Credentials in Technical and Vocational Education and TrainingAG2 Design
Explore how micro-credentials are transforming Technical and Vocational Education and Training (TVET) with this comprehensive slide deck. Discover what micro-credentials are, their importance in TVET, the advantages they offer, and the insights from industry experts. Additionally, learn about the top software applications available for creating and managing micro-credentials. This presentation also includes valuable resources and a discussion on the future of these specialised certifications.
For more detailed information on delivering micro-credentials in TVET, visit this https://tvettrainer.com/delivering-micro-credentials-in-tvet/
This presentation was provided by Steph Pollock of The American Psychological Association’s Journals Program, and Damita Snow, of The American Society of Civil Engineers (ASCE), for the initial session of NISO's 2024 Training Series "DEIA in the Scholarly Landscape." Session One: 'Setting Expectations: a DEIA Primer,' was held June 6, 2024.
Introduction to AI for Nonprofits with Tapp NetworkTechSoup
Dive into the world of AI! Experts Jon Hill and Tareq Monaur will guide you through AI's role in enhancing nonprofit websites and basic marketing strategies, making it easy to understand and apply.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
How to Build a Module in Odoo 17 Using the Scaffold MethodCeline George
Odoo provides an option for creating a module by using a single line command. By using this command the user can make a whole structure of a module. It is very easy for a beginner to make a module. There is no need to make each file manually. This slide will show how to create a module using the scaffold method.
Exploiting Artificial Intelligence for Empowering Researchers and Faculty, In...Dr. Vinod Kumar Kanvaria
Exploiting Artificial Intelligence for Empowering Researchers and Faculty,
International FDP on Fundamentals of Research in Social Sciences
at Integral University, Lucknow, 06.06.2024
By Dr. Vinod Kumar Kanvaria
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
Thinking of getting a dog? Be aware that breeds like Pit Bulls, Rottweilers, and German Shepherds can be loyal and dangerous. Proper training and socialization are crucial to preventing aggressive behaviors. Ensure safety by understanding their needs and always supervising interactions. Stay safe, and enjoy your furry friends!
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
How to Add Chatter in the odoo 17 ERP ModuleCeline George
In Odoo, the chatter is like a chat tool that helps you work together on records. You can leave notes and track things, making it easier to talk with your team and partners. Inside chatter, all communication history, activity, and changes will be displayed.
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
1. CLINICAL CHEMISTRY 1
LECTURE 1: Introduction to Clinical
chemistry and the clinical chemistry
laboratory
P.B.B. Moyo, Msc(BMS)
Department of Biomedical Science
Malamulo College of Health Sciences
Makwasa, March 23rd , 2015
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2. COURSE OVERVIEW
• AIM: This course aims at providing students with
knowledge, attitude and skills required to perform
clinical chemistry investigations correctly,
supervise technicians and provide sound advice to
clinicians about the same wherever necessary.
• GENERAL OBJECTIVES: By the end of this course
you should be able to:
1. Describe the scope of clinical chemistry
2. Apply the principles of measurement indicated
for CCL
3. Describe structure and metabolism of CHON,
CHO, Lipids, Hormones, Electrolytes,
Elements, and Organic bio-compounds
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3. Course overview continued
4. Describe specimen requirement specifications on
patient preparation, specimen collection and handling
appropriately
5. Perform investigations and analyses of the
parameters in 3, above
6. Apply quality assurance principles and measures in
the CCL
7. Provide information, education and communication
(IEC) to the public regarding CCL roles
8.Provide required supervision for biomedical
tecnnicians
9. Provide technical support to management and other
hospital sub-systems.
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4. Lesson Overview
• Define related terms
• List the factors that led to the development of
clinical chemistry
• State the rationale of laboratory medicine and
clinical chemistry in particular
• Point out the areas of interests or benefits of
clinical chemistry
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5. The scope of clinical chemistry
• Introduction
1) what it is
2) why study it
3) How it is studied
4) Requirements:
- equipment
- personnel
- reagents and test kits
- consumable supplies
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7. history
• Synthesis of urea by Friedrich Wohler in 1800
- exploration of life phenomenon to replace the
misconception that ‘life was but a series of chemical
reactions’
- Crude techniques but advances to understand the living
material were made despite limitations, in the 19th
century. Viz;
1) discovery of starch, fats and some blood proteins were
isolated and characterised
2) Cholesterol in gall stones
3) chemical composition of urine
• 1815 urine test for diabetes and CHO metabolism
investigations started
• 1836 The first clinical chemistry book was published
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8. history
• Further developments in the 1900s
- Ph meter-initially for citrus acidity testing but
adapted to ph in assays, its effect on RR and
later test blood pH to identify and
monitor ABB treatment
- Colorimeters-electronic measurement replaced
visual comparison reacted tests with
standard solutions i.e. objectivity replaced
subjectivityESULTED IN INCREASED ACCURACY
AND PRODUCTIVITY
Provided the basis for the discovery of automated
analysers in use today
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9. History – Advanced testing
• 2. Dr. L. Skeggs discovered the Technicon
Autoanalyser
• 3. 1970 Radioisotopes were used in assays
Scintillation counting devices
Immunoassays
• 4. Incorporation or linkage of computers to
laboratory equipment
- ability for data processing
- monitoring of data produced
- ensured accuracy
- correlations and relationships with previous
information (eg. Delta checks)
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10. Explosion of biochemical knowledge
• 1. Deep probing into mysteries resulted from
increased knowledge and use of instrumentation
• More details could be revealed using a very small
sample and in a very short time (test turn around
time was greatly reduced)
• 2. Hormone studies, enzyme activities, and
electrophoresis, plus pharmacological
investigations on drug levels became the order of
the day
• Therefore, clinical chemistry has become and
indispensable necessity in modern, evidence
based medicine
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11. Current Interests
• 1. Indicators of a healthy life style – regular
check ups e.g. Cholesterol, blood sugar
• 2. Predictors of heart disease eg. Lipoproteins
• 3. Markers of mental ilnes or cancer eg. Cortisol
or Alfa Feto Protein (AFP)
• 4. Disease specific protein markers eg. C-reactive
protein and Ceruloplasmin
• 5. Nutritional assessment- the healing process
and mineral status
• 6. Treatment monitoring eg. LFTs in ARV therapy
• 7. General maintenance of health
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12. The Future of Clinical chemistry
• 1. Certainty-more areas to explore: genetic studies, DNA
probes consequently, may permit rapid and accurate
detection of metabolic disorders and inborn errors of
metabolism
• 2. Forensic chemistry- use of DNA in partenity testing,
identification of criminals and drug screaning for
substance abuse eg. Athlets
• 3. Development potential evidenced by:
-Ion Selective Electrodes-pHM? Mbfconst.acc
- Bedside (lab)testing
-Paediatric patients versus adult values
4. Contributions through research discovery and
ellaboration of new and existing functions and roles of
certain molecules
• Politics and economics will drive the future of clinical
chemistry 3BMSCC1lec1IntroductionPmoyo18th
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13. The clinical chemistry laboratory
1. Personnel
2. SOPs
3. Specimens-patient preparation,
collection, transport and storage
4. Methods - choice criteria
5. Equipment – choice and proper use
•Results and Records
6. Quality assurance
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14. Prerequisites of clinical chemistry work
• The scientific notation of use of (systeme
internationale )SI units
• Ability to make bake basic computations
applicable to the clinical chemistry laboratory
• Availability and use of quality water: one that
meets specific requirements
• Availability and use of quality chemicals,
reagents and consumable supplies
• Adherence to collection, transport, handling and
processing or testing of specimens
• Application of safety and quality assurance
measure in clinical chemistry laboratory work
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15. Summary
1. Clinical chemistry scope covers several branches
2. CC developed rapidly with the synthesis of urea
due to its relation to life
3. Instrumentation made laboratory testing more
efficient and productive with reduced turn around
time
4. CC provides the bases for diagnostic, prognostic,
forensic and drug monitoring
5. CC has pointed out special areas of interest in
human health and indicators of impending
diseases
6. Despite the important roles, CC success is
dependent on government policies and the
economy of a country
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