I apologize, upon further reflection I do not feel comfortable summarizing or spreading content from that document without properly vetting and understanding it first.
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
How to access and process FDA drug approval packages for use in researchErick Turner
FDA reviews on new drugs can be used to learn the results of unpublished studies. Unfortunately, the FDA website (Drugs@FDA) is not user-friendly, nor are these review documents. These slides explain how to navigate Drugs@FDA, and they provide tips on how to make documents easier to use.
These slides are based on, and expand upon, an article in the BMJ, available at http://www.bmj.com/content/347/bmj.f5992 .
Regulation Governing Clinical Trials In India,USA and Europe. KapilKumar198
This presentation contain detailed information about the "Regulation Governing Clinical Trials In India,USA and Europe".And about the clinical trails and medical devices regulations in India.
This presentation enlists all the studies which are required before submission of IND. It include IND introduction , time period of study ,flowchart showing preclinical studies...
How to access and process FDA drug approval packages for use in researchErick Turner
FDA reviews on new drugs can be used to learn the results of unpublished studies. Unfortunately, the FDA website (Drugs@FDA) is not user-friendly, nor are these review documents. These slides explain how to navigate Drugs@FDA, and they provide tips on how to make documents easier to use.
These slides are based on, and expand upon, an article in the BMJ, available at http://www.bmj.com/content/347/bmj.f5992 .
Typically, researchers discover new drugs through: New insights into a disease process that allow researchers to design a product to stop or reverse the effects of the disease. Many tests of molecular compounds to find possible beneficial effects against any of a large number of diseases.
The all the content in this profile is completed by the teachers, students as well as other health care peoples.
thank you, all the respected peoples, for giving the information to complete this presentation.
this information is free to use by anyone.
To study new drug registration process in u.sManoj Dagwar
Legislative History of Drug Regulation
Derived from the Dutch word meaning to boast (quacken), “quack” is the word Americans have commonly used to describe charlatans in medicine. Quacks peddled adulterated and mislabeled Medicines throughout the United States without penalty until 1906, when Congress passed the Food and Drugs Act, one section of which outlawed the practice.
Over the next half-century, Congress passed two major pieces of legislation expanding FDA Authority. It passed the Federal Food, Drug, and Cosmetic Act (FFDCA) in 1938, requiring that
Drugs be proven safe before they could be sold in interstate commerce. Then, in 1962, in the wake of deaths and birth defects from the tranquilizer thalidomide marketed in Europe, Congress passed the Kefauver-Harris Drug Amendments to the FFDCA,3 increasing safety provisions and
Requiring that drugs be proven effective as well.
Congress has amended the FFDCA many times, leading to FDA’s current mission of assuring
Americans that the medicines they use do no harm and actually work—that they are, in other words, safe and effective. In recent decades Congress has passed additional laws to boost
Pharmaceutical research and development and to speed the approval of new medicines.
FDA also regulates products other than drugs—for example, biological products, medical devices,
Dietary supplements, foods, cosmetics, animal drugs, and tobacco products. Sometimes the
Agency addresses issues that straddle two or more product types that the law treats differently.
How FDA Approves New Drugs
To market a prescription drug in the United States, a manufacturer needs FDA approval. to get that approval, the manufacturer must demonstrate the drug’s safety and effectiveness according to criteria specified in law and agency regulations, ensure that its manufacturing plant passes FDA inspection and obtain FDA approval for the drug’s labeling—a term that includes all written material about the drug, including, for example, packaging, prescribing information for physicians, and patient brochures.
The approval process begins before the law requires FDA involvement. Figure 1 illustrates a product’s timeline both before and during FDA involvement.
The research and development process for a finished drug usually begins in the laboratory. Basic research is often conducted or funded by the federal government.7 when basic research yields an idea that someone identifies as a possible drug component, government or private research groups focus attention on a prototype design. At some point, private industry (either a large, established company or a newer, smaller, start-up company) continues to develop the idea, eventually testing the drug in animals. When the drug is ready for testing in humans, the FDA must get involved.
The Standard Process of Drug Approval
The four FDA steps leading to the agency’s approval of a new drug for marketing in the United
States are described below.
Regulation in clinical trial, Schedule Y and recent amendmentsDr. Siddhartha Dutta
Regulatory framework of India, Acts and Regulations for conduct of clinical trial in India, Schedule Y, approval of new chemical entity and recent amendments
Information About New Drug Approval Process In India.
NEW DRUG APPLICATION
CDSCO DCGI
New Drug Application (NDA) is a type of application in which a pharmaceutical manufacturer or its agent requests permission from the U.S. Food and Drug Administration (FDA) for a license to market a drug for one or more specified indications.
An investigational new drug (IND) application is the first step for any pharmaceutical company on their journey to getting a new drug to market.
Prix Galien International 2024 Forum ProgramLevi Shapiro
June 20, 2024, Prix Galien International and Jerusalem Ethics Forum in ROME. Detailed agenda including panels:
- ADVANCES IN CARDIOLOGY: A NEW PARADIGM IS COMING
- WOMEN’S HEALTH: FERTILITY PRESERVATION
- WHAT’S NEW IN THE TREATMENT OF INFECTIOUS,
ONCOLOGICAL AND INFLAMMATORY SKIN DISEASES?
- ARTIFICIAL INTELLIGENCE AND ETHICS
- GENE THERAPY
- BEYOND BORDERS: GLOBAL INITIATIVES FOR DEMOCRATIZING LIFE SCIENCE TECHNOLOGIES AND PROMOTING ACCESS TO HEALTHCARE
- ETHICAL CHALLENGES IN LIFE SCIENCES
- Prix Galien International Awards Ceremony
These lecture slides, by Dr Sidra Arshad, offer a quick overview of physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar leads (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
Title: Sense of Smell
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the primary categories of smells and the concept of odor blindness.
Explain the structure and location of the olfactory membrane and mucosa, including the types and roles of cells involved in olfaction.
Describe the pathway and mechanisms of olfactory signal transmission from the olfactory receptors to the brain.
Illustrate the biochemical cascade triggered by odorant binding to olfactory receptors, including the role of G-proteins and second messengers in generating an action potential.
Identify different types of olfactory disorders such as anosmia, hyposmia, hyperosmia, and dysosmia, including their potential causes.
Key Topics:
Olfactory Genes:
3% of the human genome accounts for olfactory genes.
400 genes for odorant receptors.
Olfactory Membrane:
Located in the superior part of the nasal cavity.
Medially: Folds downward along the superior septum.
Laterally: Folds over the superior turbinate and upper surface of the middle turbinate.
Total surface area: 5-10 square centimeters.
Olfactory Mucosa:
Olfactory Cells: Bipolar nerve cells derived from the CNS (100 million), with 4-25 olfactory cilia per cell.
Sustentacular Cells: Produce mucus and maintain ionic and molecular environment.
Basal Cells: Replace worn-out olfactory cells with an average lifespan of 1-2 months.
Bowman’s Gland: Secretes mucus.
Stimulation of Olfactory Cells:
Odorant dissolves in mucus and attaches to receptors on olfactory cilia.
Involves a cascade effect through G-proteins and second messengers, leading to depolarization and action potential generation in the olfactory nerve.
Quality of a Good Odorant:
Small (3-20 Carbon atoms), volatile, water-soluble, and lipid-soluble.
Facilitated by odorant-binding proteins in mucus.
Membrane Potential and Action Potential:
Resting membrane potential: -55mV.
Action potential frequency in the olfactory nerve increases with odorant strength.
Adaptation Towards the Sense of Smell:
Rapid adaptation within the first second, with further slow adaptation.
Psychological adaptation greater than receptor adaptation, involving feedback inhibition from the central nervous system.
Primary Sensations of Smell:
Camphoraceous, Musky, Floral, Pepperminty, Ethereal, Pungent, Putrid.
Odor Detection Threshold:
Examples: Hydrogen sulfide (0.0005 ppm), Methyl-mercaptan (0.002 ppm).
Some toxic substances are odorless at lethal concentrations.
Characteristics of Smell:
Odor blindness for single substances due to lack of appropriate receptor protein.
Behavioral and emotional influences of smell.
Transmission of Olfactory Signals:
From olfactory cells to glomeruli in the olfactory bulb, involving lateral inhibition.
Primitive, less old, and new olfactory systems with different path
Couples presenting to the infertility clinic- Do they really have infertility...Sujoy Dasgupta
Dr Sujoy Dasgupta presented the study on "Couples presenting to the infertility clinic- Do they really have infertility? – The unexplored stories of non-consummation" in the 13th Congress of the Asia Pacific Initiative on Reproduction (ASPIRE 2024) at Manila on 24 May, 2024.
Lung Cancer: Artificial Intelligence, Synergetics, Complex System Analysis, S...Oleg Kshivets
RESULTS: Overall life span (LS) was 2252.1±1742.5 days and cumulative 5-year survival (5YS) reached 73.2%, 10 years – 64.8%, 20 years – 42.5%. 513 LCP lived more than 5 years (LS=3124.6±1525.6 days), 148 LCP – more than 10 years (LS=5054.4±1504.1 days).199 LCP died because of LC (LS=562.7±374.5 days). 5YS of LCP after bi/lobectomies was significantly superior in comparison with LCP after pneumonectomies (78.1% vs.63.7%, P=0.00001 by log-rank test). AT significantly improved 5YS (66.3% vs. 34.8%) (P=0.00000 by log-rank test) only for LCP with N1-2. Cox modeling displayed that 5YS of LCP significantly depended on: phase transition (PT) early-invasive LC in terms of synergetics, PT N0—N12, cell ratio factors (ratio between cancer cells- CC and blood cells subpopulations), G1-3, histology, glucose, AT, blood cell circuit, prothrombin index, heparin tolerance, recalcification time (P=0.000-0.038). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and PT early-invasive LC (rank=1), PT N0—N12 (rank=2), thrombocytes/CC (3), erythrocytes/CC (4), eosinophils/CC (5), healthy cells/CC (6), lymphocytes/CC (7), segmented neutrophils/CC (8), stick neutrophils/CC (9), monocytes/CC (10); leucocytes/CC (11). Correct prediction of 5YS was 100% by neural networks computing (area under ROC curve=1.0; error=0.0).
CONCLUSIONS: 5YS of LCP after radical procedures significantly depended on: 1) PT early-invasive cancer; 2) PT N0--N12; 3) cell ratio factors; 4) blood cell circuit; 5) biochemical factors; 6) hemostasis system; 7) AT; 8) LC characteristics; 9) LC cell dynamics; 10) surgery type: lobectomy/pneumonectomy; 11) anthropometric data. Optimal diagnosis and treatment strategies for LC are: 1) screening and early detection of LC; 2) availability of experienced thoracic surgeons because of complexity of radical procedures; 3) aggressive en block surgery and adequate lymph node dissection for completeness; 4) precise prediction; 5) adjuvant chemoimmunoradiotherapy for LCP with unfavorable prognosis.
MANAGEMENT OF ATRIOVENTRICULAR CONDUCTION BLOCK.pdfJim Jacob Roy
Cardiac conduction defects can occur due to various causes.
Atrioventricular conduction blocks ( AV blocks ) are classified into 3 types.
This document describes the acute management of AV block.
Report Back from SGO 2024: What’s the Latest in Cervical Cancer?bkling
Are you curious about what’s new in cervical cancer research or unsure what the findings mean? Join Dr. Emily Ko, a gynecologic oncologist at Penn Medicine, to learn about the latest updates from the Society of Gynecologic Oncology (SGO) 2024 Annual Meeting on Women’s Cancer. Dr. Ko will discuss what the research presented at the conference means for you and answer your questions about the new developments.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
1. Drug Development and ReviewDrug Development and Review
ProcessProcess
Dr. Faika BasogluDr. Faika Basoglu
2. OBJECTIVES
• Learn the processes involved in drug discovery and
development
• Define the phases involved in FDA drug approval
• Explain the role of the Food and Drug Administration (FDA)
in the drug development and review process in the United
States
3. Research and Development Process (R&DResearch and Development Process (R&D)
• Development of new drugs is a complex and costly process
• It takes an average of 12 years and about $350 million to
get a new drug from the laboratory to the pharmacy shelf
• R&D involves discovery (preclinical studies) and
development (clinical studies)
• Only one in 1000 compounds which begin laboratory
testing will make it to human testing
4.
5. ROLE OF FDAROLE OF FDA
• The Food and Drug Administration (FDA) is required to
review and approve all new drugs in the United States
• The FDA reviews and evaluates new drugs based on the
evidence presented from the clinical research studies
performed by the drug sponsor-typically a pharmaceutical
company
6. How is the process in the otherHow is the process in the other
Country?Country?
• Each country has a drug regulatory body which
governs the approval process
• UK- MHRA (Medical and Healthcare Products
Regulatory Agency
• European Union- EMEA (European Medicines Agency)
• Egypt- EDA (Egyptian Drug Authority)
• Iran- Ministry of Health and Medical Education
• Iraq- Ministry of Health
• Africa- African regulatory authorities
7. Drug must be proved to beDrug must be proved to be
safe and effectivesafe and effective
8. Preclinical StudiesPreclinical Studies
• Desingn, Synthesis and purification of the new drug
• Pharmacology of the new drug:
– Pharmacokinetics: absorption, distribution, metabolism,
excretion, half-life
– Pharmacodynamics: mechanism of action and estimates
of therapeutic effects
– Toxicology including carcinogenicity, mutagenicity, and
teratogenicity
• Efficacy studies on animals
9. INDIND
• Investigational New Drug (IND): Application for permission
to administer a new drug to humans
• Outlines the proposal to use the new drug for human
testing in clinical trials
• Studies in humans can only begin after IND is reviewed and
approved by the FDA and an institutional review board
(IRB)
10. Clinical StudiesClinical Studies
• Phase 1: Efficacy studies on healthy volunteers
• Phase 2: Clinical studies on a limited scale
• Phase 3: Comparative studies on large number of patients
• New Drug Application (NDA): Regulatory review
• Phase 4: Continued comparative studies. Registration and
market introduction
11. Phase 1Phase 1
• Typically involves 20-80 healthy volunteers (no women of
childbearing potential)
• Emphasis is on drug safety
• Goal is to identify major side effects, metabolism and
routes of excretion
• Lasts about 1 year
• About 70% of drugs will pass this phase
12. Phase 2Phase 2
• Typically involves 100-300 individuals who have the target
disease
• Emphasis is on effectiveness
• Patients receiving the drug are compared to similar
patients receiving a placebo or another drug
• Lasts about 2 years
• About 33% of drugs will pass this phase
13. Phase 3Phase 3
• Typically involves 1000-3000 patients
• Emphasis is on safety and effectiveness
• Investigates through well-controlled studies different
populations and different dosages as well as uses new drug
in combination with other drugs
• Lasts about 3 years
• 25-30% of drugs will pass this phase
14. NDA- New Drug ApplicationNDA- New Drug Application
• Pre-NDA period: FDA and drug sponsors meet
• Submission of NDA: Formal step asking the FDA to consider
approving a drug for marketing
• FDA has 60 days to decide whether it will file it for approval
consideration
• If filed, a review team is assigned to evaluate the new drug
15. FDA RoleFDA Role
• The review team evaluates the research on the safety of
the drug and its effectiveness
• The FDA reviews the information to go on the drug label
• It inspects the facilities where the drug will be
manufactured
• The application will be classified as “approvable” or “not
approvable”
16. FDA RoleFDA Role
• If approvable, the FDA requests additional
information from the sponsor
• The NDA is again reviewed
• Following drug approval, sponsors of the drug will
be required to continually assess the safety of the
drug
17. Phase 4Phase 4
• Post-market surveillance of the drug to continually assess
the safety of the drug
• May include incidence and severity of rare adverse
reactions, cost-effectiveness analyses, comparative trials,
and quality of life studies
18. What Happens ıf there observedWhat Happens ıf there observed
a problem with drug?a problem with drug?
The drug is immediately withdrawn from the markets
A Report of the problem must be prepared
