Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
Research Methodology_UNIT_I_General Research Methodology M. Pharm (IIIrd Sem.)Prachi Pandey
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
Medical Research: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
Research Methodology_UNIT_I_General Research Methodology M. Pharm (IIIrd Sem.)Prachi Pandey
General Research Methodology: Research, objective, requirements, practical
difficulties, review of literature, study design, types of studies, strategies to eliminate
errors/bias, controls, randomization, crossover design, placebo, blinding techniques.
(I) MEDICAL RESEARCH_ UNIT_III_RESEARCH METHODOLOGY & BIOSTATISTICS.pptxRAHUL PAL
Research Methodology and Biostatistics syllabus:
Medical Research: History, values in medical ethics, autonomy, beneficence, non-maleficence, double effect, conflicts between autonomy.
Medical research has a long and varied history. It has evolved from rudimentary practices to sophisticated, evidence-based methodologies. Some key milestones include the development of the scientific method, the use of randomized controlled trials, the discovery of antibiotics, and the mapping of the human genome. Ethical concerns have also played a significant role in shaping the history of medical research, especially in response to various ethical violations, such as the Tuskegee Syphilis Study and the Nuremberg Trials.
Resolving conflicts between these principles often requires careful consideration, ethical analysis, and, in some cases, consultation with ethics committees or boards. The specific course of action may vary based on the individual circumstances and ethical frameworks employed by healthcare professionals and researchers. Ethical guidelines and regulations also play a significant role in addressing and preventing these conflicts in medical research.
MEDICAL RESEARCH: UNIT_III_ EUTHANASIA, COI, CONFIDENTIALITY RESEARCH METHODO...RAHUL PAL
Medical research in clinical settings is the study of human health and disease in people. It is the primary way that researchers determine if a new form of treatment or prevention, such as a new drug, diet, or medical device, is safe and effective in people.
A clinical trial is designed to learn if a new treatment is more effective or has less harmful side effects than existing treatments.
Clinical trail is basically have 4 phases: Phase I, Phase II, Phase III, Phase IV
Medical Research: conflicts between autonomy and beneficence/non maleficence, euthanasia, informed consent, confidentiality, criticisms of orthodox medical ethics
Cross over design, Placebo and blinding techniques Dinesh Gangoda
A crossover design is a modified randomized block design in which each block receives more than one treatment at different dosing periods.
A block can be a patient or a group of patients.
Patients in each block receive different sequences of treatments.
A crossover design is called a complete crossover design if each sequence contains all treatments under investigation.
A placebo is a dummy medicine containing no active substance.
This substance has no therapeutic effect, used as a control in testing new drugs.
Latin- ‘ I shall please’
Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Lab...RAHUL PAL
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal
hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
The Declaration of Helsinki is a set of ethical principles and guidelines for conducting medical research involving human subjects. It was adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times since then, with the most recent revision occurring in 2013.
The Declaration of Helsinki outlines several key principles and considerations for researchers and physicians involved in human research, with a focus on protecting the rights, safety, and well-being of research participants. Some of the core principles and points covered in the Declaration of Helsinki include:
Informed Consent: Research participants must provide voluntary, informed, and written consent to participate in a study. They should be fully informed about the nature of the research, its purpose, risks, benefits, and alternatives.
Beneficence and Non-Maleficence: Researchers should aim to maximize the benefits of research while minimizing harm to participants. The well-being of the research subjects should be the primary concern.
Research Ethics Committee Review: All research involving human subjects should undergo ethical review by an independent committee. This review ensures that the study meets ethical and scientific standards.
Scientific Validity and Ethical Conduct: Research should be scientifically rigorous and designed to answer important questions. Researchers must conduct their work with integrity and honesty.
Privacy and Confidentiality: Participants' privacy should be protected, and their data should be kept confidential. Personal information should not be disclosed without informed consent.
Equitable Distribution of Benefits and Burdens: Research should benefit society, and the selection of research subjects should be fair, without exploitation or discrimination.
Continuing Review: Ethical review of research should continue throughout the duration of the study, with particular attention to any new information that may affect the research's ethical considerations.
Access to Medical Care: Participants should have access to medical care and treatment, and they should be compensated for any injuries resulting from their participation in research.
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)Prachi Pandey
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
General Research Methodology: Research, objective, requirements,
practical difficulties, review of literature, study design, types of studies,
strategies to eliminate errors/bias, controls, randomization, crossover design,
placebo, blinding techniques.
Criticisms of orthodox medical ethics, importance ofsupriyawable1
ethics is a very large and complex field of study with many branches .medical ethics is the branch of ethics that deals moral issues in medical practice. principles of medical ethics - autonomy ,beneficence ,confidentiality,do not harm,equity .importance of communication .
Clinical Aspect of Drug Discovery and Development PCO 413.pptxCoutyNess
Clinical trials helps in the discovery and development of drugs which helps to improve health, drug discovery and development is a key aspect of medicine which ensure more improved drugs are been developed to improve health in the society
Cross over design, Placebo and blinding techniques Dinesh Gangoda
A crossover design is a modified randomized block design in which each block receives more than one treatment at different dosing periods.
A block can be a patient or a group of patients.
Patients in each block receive different sequences of treatments.
A crossover design is called a complete crossover design if each sequence contains all treatments under investigation.
A placebo is a dummy medicine containing no active substance.
This substance has no therapeutic effect, used as a control in testing new drugs.
Latin- ‘ I shall please’
Research Methodology (M. Pharm, IIIrd Sem.)_UNIT_IV_CPCSEA Guidelines for Lab...RAHUL PAL
CPCSEA guidelines for laboratory animal facility: Goals, veterinary care, quarantine,
surveillance, diagnosis, treatment and control of disease, personal
hygiene, location of animal facilities to laboratories, anesthesia, euthanasia, physical facilities, environment, animal husbandry, record keeping, SOPs, personnel and
training, transport of lab animals.
The Declaration of Helsinki is a set of ethical principles and guidelines for conducting medical research involving human subjects. It was adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times since then, with the most recent revision occurring in 2013.
The Declaration of Helsinki outlines several key principles and considerations for researchers and physicians involved in human research, with a focus on protecting the rights, safety, and well-being of research participants. Some of the core principles and points covered in the Declaration of Helsinki include:
Informed Consent: Research participants must provide voluntary, informed, and written consent to participate in a study. They should be fully informed about the nature of the research, its purpose, risks, benefits, and alternatives.
Beneficence and Non-Maleficence: Researchers should aim to maximize the benefits of research while minimizing harm to participants. The well-being of the research subjects should be the primary concern.
Research Ethics Committee Review: All research involving human subjects should undergo ethical review by an independent committee. This review ensures that the study meets ethical and scientific standards.
Scientific Validity and Ethical Conduct: Research should be scientifically rigorous and designed to answer important questions. Researchers must conduct their work with integrity and honesty.
Privacy and Confidentiality: Participants' privacy should be protected, and their data should be kept confidential. Personal information should not be disclosed without informed consent.
Equitable Distribution of Benefits and Burdens: Research should benefit society, and the selection of research subjects should be fair, without exploitation or discrimination.
Continuing Review: Ethical review of research should continue throughout the duration of the study, with particular attention to any new information that may affect the research's ethical considerations.
Access to Medical Care: Participants should have access to medical care and treatment, and they should be compensated for any injuries resulting from their participation in research.
Choice of control group in clinical trialsNagendra SR
To describe the general principles involved in choosing a control group for clinical trials intended to demonstrate the efficacy of a treatment and to discuss related trial design and conduct issues.
Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)Prachi Pandey
Declaration of Helsinki: History, introduction, basic principles for all medical research, and additional principles for medical research combined with medical care.
General Research Methodology: Research, objective, requirements,
practical difficulties, review of literature, study design, types of studies,
strategies to eliminate errors/bias, controls, randomization, crossover design,
placebo, blinding techniques.
Criticisms of orthodox medical ethics, importance ofsupriyawable1
ethics is a very large and complex field of study with many branches .medical ethics is the branch of ethics that deals moral issues in medical practice. principles of medical ethics - autonomy ,beneficence ,confidentiality,do not harm,equity .importance of communication .
Clinical Aspect of Drug Discovery and Development PCO 413.pptxCoutyNess
Clinical trials helps in the discovery and development of drugs which helps to improve health, drug discovery and development is a key aspect of medicine which ensure more improved drugs are been developed to improve health in the society
The most important figures in the history of medical research is Louis
Pasteur. Pasteur was is known as medical microbiologist. A French
chemist and microbiologist who made significant contributions to the
understanding of infectious diseases. In the 1860s, Pasteur showed that
germs caused disease and that they could be killed by heat.
This discovery led to the development of pasteurization, a process of
heating food to kill harmful bacteria
Adithyaelearning provides SAS CDM Online Training to the candidates having knowledge in the SAS. Throughout this course the participants will become qualified on the Clinical programming models as well as their usage in field of clinical research. The center areas for the course incorporate data integration, data manipulation, data listings production, figures and tables as per Statistical Examination Plan, as well as generation of reports and graphs. Besides this participants can be trained based on fundamental principles as well as concepts in the statistical methodology as well as clinical trials.
The Thalidomide tragedy is one of the most devastating events in the history of medicine and drug regulation. Thalidomide was a medication that was introduced in the late 1950s and early 1960s as a sedative and treatment for nausea during pregnancy. However, its use led to a widespread public health crisis with severe and tragic consequences.
Here's an overview of the Thalidomide tragedy:
Overview of Pharmacovigilance by Yash Dhikale | Zumbar Pote | Santosh Ghuge |...ijtsrd
Clinical research is an essential component of medical advancement, focusing on understanding health and disease to enhance healthcare practices. This exploration encompasses clinical trials, classified into interventional studies and observational studies. Interventional studies, or clinical trials, involve assigning participants interventions to evaluate their effects on health outcomes. These interventions can range from drugs to surgical procedures or preventive care. Clinical trials progress through four phases, ensuring safety and efficacy before widespread implementation. The International Clinical Trials Registry Platform ICTRP , a global initiative by WHO, facilitates comprehensive and accessible information on human clinical trials. ICTRP strives to enhance data accuracy, raise awareness about trial registration, and promote data utilization. This collaborative effort fosters transparency, benefiting not only researchers but also patients, families, and the broader healthcare community. Yash Dhikale | Zumbar Pote | Santosh Ghuge | Shital B. Thakre | Dipali S. Shegar "Overview of Pharmacovigilance" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-8 | Issue-1 , February 2024, URL: https://www.ijtsrd.com/papers/ijtsrd63464.pdf Paper Url: https://www.ijtsrd.com/pharmacy/other/63464/overview-of-pharmacovigilance/yash-dhikale
Exploring Clinical Trials: How Research Can Help Us Better Detect, Diagnose, ...Ruchi Vahi
The exploration of clinical trials has become increasingly important in the medical field, with each trial providing insight into how we can better detect, diagnose and treat diseases. In this article, we will be looking at the different aspects of clinical research and trial processes, as well as discussing the importance of these studies in advancing healthcare treatments.
Visit us: https://mprex.in/project/late-phase-clinical-trials-and-research/
Similar to Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.) (20)
Software Used In Formulation Design Process- Minor Project [Bachelor].pdfRAHUL PAL
In the field of formulations, various software tools are commonly used to streamline and optimize the development process. One such software is formulation management software, which helps in creating and managing formulations by allowing scientists to input ingredient quantities, calculate costs, and analyze ingredient interactions. Additionally, simulation software like computational fluid dynamics (CFD) programs are utilized to model and predict how formulations will behave under different conditions, aiding in the design of efficient manufacturing processes. Furthermore, statistical analysis software plays a crucial role in analyzing experimental data and optimizing formulations based on statistical models, ensuring that the final product meets desired specifications. Overall, these software tools enhance productivity, accuracy, and efficiency in the formulation development workflow.
Major Project (B. Pharm) OPIUM POPPY PROJECT.pdfRAHUL PAL
Opium cultivation, an ancient practice rooted in regions like the Golden Triangle and Golden Crescent, involves a meticulous process blending nature and human intervention. Picture a serene landscape with gently rolling hills blanketed in lush greenery. Amidst this verdant tapestry stand tall, slender opium poppy plants, their delicate petals shimmering in hues of pink and white. These plants exude an air of mystique, their bulbous seed pods containing the coveted opium latex. Skilled farmers nurture these plants with utmost care, tending to their needs for water, nutrients, and protection from pests. The cultivation cycle begins with sowing the poppy seeds during specific seasons conducive to their growth. As the plants mature, they blossom into exquisite flowers, each harboring the potential for opium production. The farmers deftly slit the seed pods at just the right moment, allowing the milky sap to seep out and gradually solidify into opium. This labor-intensive process demands precision and patience, as any misstep can impact the potency and quality of the opium yield. Despite its allure, opium cultivation is not without controversy and challenges. Legal restrictions, environmental concerns, and the socioeconomic impacts on communities underscore the complex nature of this age-old practice. However, for those entrenched in the art of opium cultivation, it remains a delicate dance between tradition, livelihood, and the ever-evolving dynamics of global demand and supply.
Niosomes are nanosized vesicles composed of nonionic surfactants and cholesterol that form when these compounds are dispersed in an aqueous medium. These lipid-based structures are similar to liposomes but differ in their composition, as niosomes use nonionic surfactants instead of phospholipids. The unique characteristic of niosomes lies in their ability to encapsulate both hydrophilic and hydrophobic drugs within their bilayer membrane. This feature makes them promising candidates for drug delivery systems, as they can protect the encapsulated drug from degradation, prolong its release, and enhance its bioavailability. Additionally, niosomes offer advantages such as biocompatibility, stability, and ease of preparation, making them a versatile platform for targeted drug delivery and other biomedical applications.
Niosome An Non-Ionic Surfactant Vesicles.pptxRAHUL PAL
Niosomes are novel drug delivery systems that have garnered significant interest in the pharmaceutical field. They are essentially vesicles composed of non-ionic surfactants and cholesterol, forming a bilayer structure similar to liposomes. However, unlike liposomes, which are composed of phospholipids, niosomes are formed by self-assembly of non-ionic surfactants in aqueous media. This unique composition offers several advantages such as improved drug solubility, stability, and biocompatibility.
The introduction of niosomes as drug carriers has revolutionized the field of drug delivery due to their ability to encapsulate both hydrophilic and hydrophobic drugs. This versatility allows for targeted and controlled release of therapeutics, enhancing their efficacy while minimizing side effects.
Moreover, the surface of niosomes can be modified to achieve specific targeting of drugs to desired sites within the body, thus enhancing therapeutic outcomes and reducing systemic toxicity.
Overall, niosomes hold great promise in the pharmaceutical industry and continue to be a subject of intense research for their potential applications in various fields including cancer therapy, gene delivery, and vaccine development.
𝐎𝐫𝐚𝐥 𝐏𝐚𝐩𝐞𝐫 𝐏𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧: 𝐈𝐧𝐭𝐞𝐫𝐧𝐚𝐭𝐢𝐨𝐧𝐚𝐥 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 (𝐈𝐑𝐓𝐄𝐂 𝟐.𝟎-𝟐𝟎𝟐𝟒); The Curre...RAHUL PAL
Targeted drug delivery systems are employed to administer pharmaceutical medication,
facilitating the precise delivery of drugs to specific diseased areas. Several drug delivery
systems utilise carriers such as antibodies, transdermal patches, biodegradable polymers,
nanoparticles (NPs), liposomes, niosomes, and microspheres. Niosomes, on the other hand,
represent a promising and innovative category of vesicular systems. Niosomes are vesicles
formed by hydrating a combination of nonionic surfactants and cholesterol. These non-ionic
surfactant vesicles serve as carriers for both amphiphilic and lipophilic drugs. In the drug
delivery system using niosomes, the medication is enclosed within a vesicle. Niosomes in
tuberculosis (TB) possess biodegradable and biocompatible properties, are non-immunogenic,
and demonstrate versatility in their structural composition. It’s a serious and potentially deadly
infectious disease caused by a bacteria called Mycobacterium tuberculosis. In the recent
update, WHO still estimates 9.9 million new TB cases in 2022 at the latest. Involvement of
niosomes improves the treatment of TB with much more advanced technology and an advanced
drug nanocarrier with better treatment. The main highlights of this review paper are to
summarise the structure, compositions, preparation methods, and ICH stability guidelines for
the formulation of niosomes and their applications in TB with their several stages of treatment
by niosomal formulations.
Introduction: This study explores the use of Response Surface Methodology (RSM), a statistical optimization technique, to optimize the SR properties of prochlorperazine maleate (PCM) matrix tablets. PCM is a phenothiazine derivative used for treating schizophrenia, nausea, and vomiting. Sustained-release formulations offer extended drug delivery, potentially improving patient compliance and reducing side effects. RSM helps identify optimal combinations of critical formulation factors influencing drug release, such as polymer type and concentration, filler type, and drug/polymer ratio. The study likely involves designing experiments based on chosen RSM designs (e.g., Box-Behnken) with varying factor levels. Formulate SR tablets with different factor combinations. Evaluating the drug release profiles of each tablet formulation. Analyzing data using RSM software to build mathematical models relating factors to drug release and identifying optimal factor combinations that maximize desired release characteristics.
Objective: The ongoing research purpose to improve the advancement of a sustained release tablet containing Phenothiazine derivative PCM loaded matrix. This is achieved by utilizing DoE as a computational method to statistically validate the formulation.
THE CURRENT STATUS IN MUCOSAL DRUG DELIVERY SYSTEM (MDDS) AND FUTURE PROSPECT...RAHUL PAL
This systematic review aims to provide a comprehensive overview of the current status of
mucosal drug delivery systems (MDDS) and explore their future prospects in drug delivery.
MDDS have gained significant attention in recent years due to their potential to enhance drug
absorption, improve therapeutic efficacy, and minimize systemic side effects. This review
critically evaluates the existing literature on MDDS, including various mucosal routes such as
oral, nasal, ocular, pulmonary, and vaginal delivery. Additionally, it discusses the challenges
associated with MDDS, such as formulation development, stability, and regulatory
considerations. Furthermore, this review highlights emerging technologies and innovative
strategies that hold promise for the future of MDDS. Overall, this systematic review provides
valuable insights into the current landscape of MDDS and offers recommendations for future
research and development in this field.
Design of Experiments (DoE) manipulation in the formulation and optimization ...RAHUL PAL
Introduction: In India, the regulatory body for catechu is the Food Safety and Standards Authority of
India (FSSAI). The FSSAI is responsible for regulating the manufacture, sale, and distribution of food in
India, including catechu. The FSSAI has set standards for the purity and quality of catechu, and it also
monitors the market for adulterated catechu. The FDA (The Food and Drug Administration) is
responsible for regulating the safety and efficacy of drugs and dietary supplements in the United States
(US). The FDA has not approved catechu as a drug or dietary supplement, but it does regulate catechu as
a food additive. The FDA has set limits on the amount of catechu that can be added to food
Objective: The primary objective of this research was to involvement of design of experiments (DoE)
manipulation in the formulation and optimization of a traditional Ayurvedic medicine derived from dried
extract of Senegalia catechu enhanced through statistical analysis.
Methodology: The dried extract of Senegalia catechu was collected and identified at the botanical
herbarium garden. Subsequently, it underwent a drying process and was ground into a powder.
The Utilization of 32 Full Factorial Design (FFD) for Optimization of Linco...RAHUL PAL
Objectives: The ongoing research aims to enhance the development of LNH-loaded nanogel by
utilizing DoE as the computational method to statistically validate their formulation.
Methodology: In this research Chitosan used as a natural polymer and Poly (Ethylene glycol)
[PEG] as a penetration or permeation enhancer. The different nanogel of LNH were synthesized
using the Nanoprecipitation and Dispersion method, with variations in the drug-polymer ratio
(1/0.03, 1/0.08, 1/0.12). The process parameters were carefully optimizing for enhance the
efficiency of the synthesis. To achieve this, optimization studies were conducted using 3² FFD,
employing the Design Expert Software Trial version 10.0.7. The total of 13 runs were generated to
ensure comprehensive analysis and evaluation of the procedure. The selected independent
variables included the concentration of Chitosan (R1) and Carbopol 934 (R2). The dependent
variables, on the other hand, were particle size (P1), Polydispersity Index (P2), and % Drug release
(P3), chosen in that order. By employing this optimization technique, one can acquire valuable
information in a manner that is both efficient and cost-effective. This approach facilitates a deeper
comprehension of the relationship between controllable independent variables and the performance
and quality of the Nanogels being produced.
Determination of Partition coefficient of Known and Unknown drug.pdfRAHUL PAL
Partition coefficient, often denoted as P or P_oct, is a measure of how a solute distributes between two immiscible (unmixable) solvents. It is commonly used in chemistry, biochemistry, and pharmacology to understand the distribution of a compound between different phases, such as between a hydrophobic organic solvent and water. In experimental settings, the partition coefficient is determined by measuring the concentrations of the solute in each phase. The values obtained provide insights into the solute's behavior and can guide decisions in various scientific and industrial processes.
A pharmaceutical suspension is a heterogeneous system in which finely divided solid particles are dispersed in a liquid medium. Unlike solutions, where solutes are completely dissolved, suspensions involve particles that are only partially soluble or insoluble in the liquid. These suspensions are commonly used in the pharmaceutical industry to deliver medications that may be poorly soluble or unstable in their pure form. The solid particles, often in the form of powders or crystals, are dispersed throughout the liquid phase, creating a stable mixture through the use of suspending agents or stabilizers. These agents prevent the settling of particles, ensuring uniform distribution and ease of redispersion upon shaking before administration. Pharmaceutical suspensions offer advantages in terms of flexibility in dosing and formulation, enabling the delivery of therapeutic agents in various forms such as oral liquids, injectables, or topical preparations, enhancing patient compliance and therapeutic efficacy. The formulation and stability of pharmaceutical suspensions require careful consideration of factors such as particle size, density, and the choice of stabilizers to maintain a consistent and reliable product.
PHARMACEUTICAL SUPPOSITORIES & PESSARIES.pptRAHUL PAL
Suppositories and pessaries are both types of medication delivery systems that are designed to be inserted into body orifices for therapeutic purposes. While they serve similar functions, they are used in different parts of the body.
Suppositories:
Usage: Suppositories are typically designed for rectal or vaginal administration.
Composition: They are solid, bullet-shaped or cone-shaped dosage forms that contain medication in a base that melts or dissolves at body temperature.
Rectal Suppositories: Commonly used for medications that need to bypass the digestive system or when a patient cannot take medications orally. They are inserted into the rectum.
Vaginal Suppositories: Often used for localized treatment of gynecological conditions, such as yeast infections or hormonal therapy. They are inserted into the vagina.
Pessaries:
Usage: Pessaries are specifically designed for vaginal administration.
Composition: They are solid, oval-shaped or ring-shaped devices made of various materials such as silicone, rubber, or plastic.
Indications: Pessaries are mainly used to support the uterus, bladder, or rectum in cases of pelvic organ prolapse. However, they can also be used for the controlled release of medication into the vagina for the treatment of local conditions.
Maintenance: Pessaries need to be fitted by a healthcare professional and should be cleaned and reinserted regularly.
Partition Coefficient Determination (Pharmaceutics Practical).pptxRAHUL PAL
Partition coefficients are a fascinating and important concept in many fields, from chemistry and environmental science to medicine and pharmacology. They tell us about how a substance will distribute itself between two immiscible phases, like how a drug might move between your blood and tissues, or how a pollutant might spread through soil and water.
A partition coefficient, denoted as P or log P, describes the ratio of the concentration of a compound in one phase (usually organic) to its concentration in another phase (often water) at equilibrium.
Higher values of P indicate a greater preference for the organic phase, meaning the compound is more lipophilic (fat-loving).
Lower values of P suggest a higher affinity for the aqueous phase, implying the compound is more hydrophilic (water-loving).
The Utilization of Response Surface Methodology (RSM) In the Optimization of ...RAHUL PAL
The objective of the current studies to enhance the formulation of DS-loaded liposomes through the utilization of Response surface methodology (RSM) and involving the computation approach for their validation.
Investigational outcome represents the perceived responses were in related with the desired values and this represents the relationship of the RSM for optimization of % DR and % EE in DS loaded liposomal preparations.
Research Article Published: "Optimization and formulation of dox loaded lipos...RAHUL PAL
Doxorubicin (DOX) is a potent anticancer drug, but it is also associated with significant side effects, such as cardiotoxicity. Liposomal encapsulation of DOX can help to reduce these side effects and improve the drug's efficacy.
There are a number of different factors that can affect the optimization and formulation of DOX-loaded liposomes, including:
Lipid composition: The type and ratio of lipids used to form the liposomes can affect their size, stability, and drug encapsulation efficiency. Some commonly used lipids for DOX liposomes include hydrogenated soy phosphatidylcholine (HSPC), cholesterol, and distearoylphosphatidylglycerol (DSPG).
Drug loading method: There are a number of different methods for loading DOX into liposomes. Some common methods include the ammonium sulfate gradient method, the remote loading method, and the ethanol injection method. The choice of loading method can affect the drug encapsulation efficiency and stability of the liposomes.
Liposome size: The size of the liposomes can affect their circulation time in the body and their ability to target specific tissues. Smaller liposomes tend to have a longer circulation time and are better able to penetrate tumors.
Surface modification: Liposomes can be surface-modified with various ligands to improve their targeting and delivery properties. For example, liposomes can be conjugated with antibodies to target specific cancer cells.
The optimization of DOX-loaded liposomes is typically carried out using a quality by design (QbD) approach. QbD is a systematic approach to drug development that focuses on identifying and controlling the critical quality attributes (CQAs) of the drug product. The CQAs of DOX-loaded liposomes may include particle size, drug encapsulation efficiency, stability, and in vitro and in vivo performance.
Nucleic Acid Based Therapeutics Delivery.pdfRAHUL PAL
Nucleic acid-based therapeutics (NATs) are a promising new class of drugs that have the potential to treat a wide range of diseases, including cancer, genetic disorders, and infectious diseases. NATs work by directly targeting the genetic material of cells, either to alter gene expression or to repair damaged DNA or RNA.
However, delivering NATs to cells can be challenging. Nucleic acids are large and fragile molecules, and they can be easily degraded by enzymes in the body. Additionally, NATs need to be able to cross the cell membrane and enter the cytoplasm in order to function.
Nucleic acid-based therapeutics delivery is a rapidly evolving field, and new delivery systems are being developed all the time. As delivery systems improve, NATs are becoming more and more viable as treatments for a wide range of diseases.
Prof. Mahadeva Lal Schroff is regarded as India's founder of pharmacy. He attained this distinction as a result of his accomplishments, which included steering India's pharmaceutical sector and educational system in the proper direction.1
The history of pharmacy profession or practice in India starts with opening of chemist shop in 1811 by Scotch M Bathgate opened in Kolkata. This was probably the beginning of pharmacy practice in India.
The world's oldest known prescriptions were recorded on a clay tablet in Mesopotamia (modern-day Iraq), ca. 2400 BC. This Sumerian cuneiform document describes methods for making poultices, salves and washes.
Gas Chromatography in Analytical Analysis.pptxRAHUL PAL
Gas chromatography is a common type of chromatography used in analytical chemistry for separating and analyzing compounds that can be vaporized without decomposition. Typical uses of GC include testing the purity of a particular substance, or separating the different components of a mixture.
Monoclonal Antibody-Preparation & Application - MPH201T.pptxRAHUL PAL
Monoclonal antibodies (mAbs) are proteins produced by a single type of B cell. They are identical to each other and recognize a specific antigen. Antigens are molecules that the body's immune system recognizes as foreign. When an antigen binds to a monoclonal antibody, it triggers a series of reactions that can lead to the destruction of the antigen.
Monoclonal antibodies can be used to treat a variety of diseases, including cancer, autoimmune diseases, and infections. They are also used in research and diagnostics.
Introduction to Pharmacy & Pharmaceutics.pptxRAHUL PAL
Pharmaceutics is the overall process of developing a new chemical entity into an approved therapy that is safe and effective in treating or preventing disease. It is a complex process requiring multiple scientific, medical, legal, commercial, and regulatory expertise.Pharmaceutics is the branch of pharmacy which deals with the formulation, manufacturing, evaluation, packaging of pharmaceutical dosage forms
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
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
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.
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Francesca Gottschalk - How can education support child empowerment.pptxEduSkills OECD
Francesca Gottschalk from the OECD’s Centre for Educational Research and Innovation presents at the Ask an Expert Webinar: How can education support child empowerment?
Honest Reviews of Tim Han LMA Course Program.pptxtimhan337
Personal development courses are widely available today, with each one promising life-changing outcomes. Tim Han’s Life Mastery Achievers (LMA) Course has drawn a lot of interest. In addition to offering my frank assessment of Success Insider’s LMA Course, this piece examines the course’s effects via a variety of Tim Han LMA course reviews and Success Insider comments.
Research Methodology_UNIT_V_Declaration of Helsinki M. Pharm (IIIrd Sem.)
1. DECLARATION OF HELSINKI (UNIT V)
SUBMITTED BY: PRACHI PANDEY, RAHUL PAL
M. PHARM (PHARMACEUTICS), IIIRD SEM, RESEARCH METHEDOLOGY AND BIOSTATISTICS
DEPARTMENT OF PHARMACEUTICS, NIMS INSTITUTE OF PHARMACY, NIMS UNIVERSITY, JAIPUR, RAJASTHAN,
303121, INDIA.
2. DECLARATION OF HELSINKI
It is a set of ethical principles basically for clinical trails followed by medical researchers and given by
World Medical Association.
As physician’s (investigator) duty in research is to protect the life, health, privacy and dignity of human
participant oversight by Institutional Review Board (IRB); Research Ethical Committee (REC) or Ethical
Review Board (ERB).
Declaration of Helsinki was followed by Nuremberg code (because of nazii experiments) and
Thalidomide disaster {which was a pharmacovigilance failure; where pregnant women’s morning
sickness was tried to overcome by drug that lead to delivery of babies without limbs (phocomelia)}.
9 Amendments in 1975, 1983, 1989, 1996, 2000, 2002, 2004, 2008, 2013.
Regarded as cornerstone documents for human ethics.
3. HISTORY
Adopted in June 1964.
Amendments- 1975, 1983, 1989, 1996,2000,2002,2004,2008,2013
First significant effort by medical community to regulate research.
Prior to 1947 Nuremberg code only specific countries has National policies. (Germany Russia)
Forms basis of most subsequent documents
1947 declaration of the Nuremberg Code1948 declaration of Geneva
Declaration of Geneva (1948) - the WMA binds the physician with the words. "The health of my patient
will be my first consideration".
4. GENERAL STATEMENT
Purpose- directed towards the increase of knowledge about the
human condition in relation to its social and natural environment.
Research is for the betterment of all.
Conducted- dignity and well being. professional fair treatment and
transparency no greater risk.
Evaluation- all stages of proposal (research design,
experimentation, deceleration of results, use of results) benefits and
dangers.
GOAL NEW KNOWLEDDE
5. PRINCIPLE
First Principle – Objective of study is to outweigh risk. If risk is more either modify or stop the study
along with every thing must be monitored, assessed, documented with minimum risk.
Second Principle – If vulnerable groups (pregnancy, sensitive, children, elderly, psychological issues) are
involved then increase chance additional harm protection must be provided along with consent even with
minors
Third Principle - Before human study, scientific literature, lab and animal experiments is must to be read;
statements like regarding funding, sponsors, institutional afflation's, potential conflict of interest must be
submitted; research involving humans must confirm to generally accepted scientific principles and
through knowledge of scientific literature and methods; literature review and animal experiments must be
prior to human research.
6. PRINCIPLE
Four Principle (Research Ethical Committee) – Before study, design to conduct the experiment must be
given to the National and International Ethical norms. Research submission about the final report with
study finding and conclusion in end of the study; research protocol must be reviewed by an independent
committee and conduct by medically/ scientifically qualified individuals; main aim is the participant
health, introduction to ethical committee, responsibility to check again and again, increase revolutionary
decision. If not done they have a reason to stop/ declare invalid.
Five Principle (Privacy and Confidentiality) – Human subject and information must be private. Dignity,
privacy, confidentiality, participant’s physical/ mental integrity and life of participants should be
protected.
7. PRINCIPLE
Six Principle (Informed Consent) – It is a written consent about the experiment that has to be conducted
by the volunteer independently after knowing about research and It must have aim, method, conflict of
interest, function, general outcome of study, voluntary , legally authorative represerntative.
Seven Principle (Results) – Investigators are obliged to preserve the accuracy of results, negative and
positive results should be publically available.
Eight Principle (Use of Placebo) – Intervention should be given (+) impact. CARE- avoid abuse of this
option.
Nine Priciple (Post trail Provision) – Explain human subjects and provide help.
Ten Principle (Unproven intervention in clinical practice) – Evaluate the efficacy and safety; new
information will be recorded and publically available.
8. ADDITIONAL PRINCIPLE
The physician may combine medical research with medical care, only to the extent that the research is
justified by its potential prophylactic, diagnostic or therapeutic value.
When medical research is combined with medical care, additional standards apply to protect the patients
who are research subjects.
The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best
current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no
treatment, in studies where no proven prophylactic, diagnostic or theraptic method exists.
At the conclusion of the study, every patient entered into the study should be assured of access to the best
proven prophylactic, diagnostic and therapeutic methods identified by the study.
9. ADDITIONAL PRINCIPLE
The physician should fully inform the patient which aspects of the care are related to the research. The
refusal of a patient to participate in a study must never interfere with the patient-physician relationship.
In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist
or have been ineffective, the physician, with informed consent from the patient, must be free to use
unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician's judgment it
offers hope of saving life, reestablishing health or alleviating suffering. Where possible, these measures
should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new
information should be recorded and, where appropriate, published. The other relevant guidelines of this
Declaration should be followed.