The drug development process involves lengthy preclinical and clinical testing that can take over 12 years and cost $350 million. It begins with drug discovery followed by preclinical studies to test the drug's toxicity, pharmacokinetics, and efficacy in animals. If successful, an IND application is submitted to the FDA to begin human clinical trials. Clinical trials involve 4 phases to test the drug's safety and efficacy in humans. If phase 3 is successful, an NDA is submitted for FDA review and potential approval to market the new drug. Post-approval monitoring continues to ensure safety.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Pharmacoepidemiology is the study of effects of drugs in large numbers of people.
Epidemiologic Study Designs, Reasons to perform Pharmacoepidemiology studies, Users of pharmacoepidemiology and Role of Pharmacists & other Public Health Practitioners in Pharmacoepidemiology are discussed in this presentation.
Signal detection is a process used in pharmacovigilance to identify potential safety issues or new safety information associated with a medicinal product. The goal of signal detection is to detect signals, or potential safety concerns, as early as possible in order to allow for timely risk management and safety interventions.
Signal detection typically involves analyzing large amounts of safety data, including adverse event reports, clinical trial data, post-marketing surveillance data, and other sources of safety information. The data is analyzed using statistical methods and algorithms to identify any patterns or trends that may suggest a potential safety concern.
Once a potential safety concern is identified, further investigation is typically required to confirm the signal and assess the magnitude of the risk. This may involve conducting additional studies, analyzing the available data in more detail, or consulting with regulatory agencies and other stakeholders.
Signal detection is an ongoing process that continues throughout the life cycle of a medicinal product. The process is critical for ensuring the ongoing safety and effectiveness of medicinal products, and is an important component of pharmacovigilance activities.
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Pharmacoepidemiology is the study of effects of drugs in large numbers of people.
Epidemiologic Study Designs, Reasons to perform Pharmacoepidemiology studies, Users of pharmacoepidemiology and Role of Pharmacists & other Public Health Practitioners in Pharmacoepidemiology are discussed in this presentation.
Signal detection is a process used in pharmacovigilance to identify potential safety issues or new safety information associated with a medicinal product. The goal of signal detection is to detect signals, or potential safety concerns, as early as possible in order to allow for timely risk management and safety interventions.
Signal detection typically involves analyzing large amounts of safety data, including adverse event reports, clinical trial data, post-marketing surveillance data, and other sources of safety information. The data is analyzed using statistical methods and algorithms to identify any patterns or trends that may suggest a potential safety concern.
Once a potential safety concern is identified, further investigation is typically required to confirm the signal and assess the magnitude of the risk. This may involve conducting additional studies, analyzing the available data in more detail, or consulting with regulatory agencies and other stakeholders.
Signal detection is an ongoing process that continues throughout the life cycle of a medicinal product. The process is critical for ensuring the ongoing safety and effectiveness of medicinal products, and is an important component of pharmacovigilance activities.
Pharmacovigilanc: The science & activities relating to the Detection, Assessment, Understanding and Prevention of adverse effects or any other drug related problems
The Thalidomide Tragedy (Lessons for Drug Safety and Regulation)
CLASSIFICATION OF ADRS (RAWLIN AND THOMPSON CLASSIFICATION)
Why PV is Necessary?
Objective of PV
Outcomes of Drugs
Causal Relationship
Adverse drug reaction and causality assessment scales
Classification of AE
Serious Adverse Event (SAE)
Sources of Adverse Events (AE) reports
Sources of AE Reports(Solicited Reports)
What to Report?
Who to Report?
When to Report?
Individual case data flow
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Pre-discovery
Understand the disease
Target Identification
Choose a molecule to target with a drug
Target Validation
Test the target and confirm its role in the disease
Drug Discovery
Find a promising molecule (a “lead compound”)
that could become a drug
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
INSTITUTIONAL REVIEW BOARD (IRB/IEC).pptxRAHUL PAL
The International Council on Harmonisation (ICH) defines an institutional review board (IRB) as a group formally designated to protect the rights, safety and well-being of humans involved in a clinical trial by reviewing all aspects of the trial and approving its startup. IRBs can also be called independent ethics committees (IECs).
An IRB/IEC reviews the appropriateness of the clinical trial protocol as well as the risks and benefits to study participants. It ensures that clinical trial participants are exposed to minimal risk in relation to any benefits that might result from the research.
IRB/IEC members should be collectively qualified to review the scientific, medical and ethical aspects of the trial.
Per the FDA, an IRB/IEC should have:
At least five members.
Members with varying backgrounds.
At least one member who represents a non-scientific area (a lay member).
At least one member who is not affiliated with the institution or the trial site (an independent member).
Competent members who are able to review and evaluate the science, medical aspects and ethics of the proposed trial.
Introduction to Aggregate Reporting in Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Abbreviated New Drug Application [ANDA]Sagar Savale
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
ICH - International Conference on Harmonization of Technical Requirements for Registration
of Pharmaceuticals for Human Use. It was created in 1990.
ICH established in 1990 as a joint initiative involving both regulators and research-based
industry representatives of the European Union, Japan and the USA in scientific and technical
discussion of the testing procedures required to assess and ensure the safety, quality and
efficacy of medicines.
Regulations for drug approval in USA, E.U & India
Pharmaceutical industry is the most regulated of all the industries. Regulations are put in order to develop the most efficient and safe pharmaceutical products. It takes more than 8 to 15 years to develop a new drug product & costs more than $ 800 million.
Drug Safety & Pharmacovigilance - Introduction - Katalyst HLSKatalyst HLS
Introduction to Drug Safety & Pharmacovigilance in Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Contact:
"Katalyst Healthcares & Life Sciences"
South Plainfield, NJ, USA
info@KatalystHLS.com
Pre-discovery
Understand the disease
Target Identification
Choose a molecule to target with a drug
Target Validation
Test the target and confirm its role in the disease
Drug Discovery
Find a promising molecule (a “lead compound”)
that could become a drug
A presentation outlining the various processes a chemical compound undergoes (thorough & rigorous screening procedures) before it is finally introduced into the drug market
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
Drug Development Life Cycle - Costs and RevenueRobert Sturm
Presentation explains the Drug Development Process in terms of time/costs from initial research to final manufacturing. It presents strategies for increasing profits/decreasing costs, shows the impact of generics and details how Information Technology fits into this equation. It uses research from DiMasi and Grabowski to identify drug costs and product revenue.
Drug discovery and development is and always has been the most exciting part of clinical pharmacology. It is my attempt to compile the basic concepts from various books, articles and online journals. Feel free to comment.
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.
The stages of Drug Discovery and Development processA M O L D E O R E
Drug development is the process of bringing a new pharmaceutical drug to the market once a lead compound has been identified through the process of drug discovery. It includes preclinical research on microorganisms and animals, filing for regulatory status, such as via the United States Food and Drug Administration for an investigational new drug to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application to market the drug
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Discover the innovative and creative projects that highlight my journey throu...dylandmeas
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𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
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3.0 Project 2_ Developing My Brand Identity Kit.pptxtanyjahb
A personal brand exploration presentation summarizes an individual's unique qualities and goals, covering strengths, values, passions, and target audience. It helps individuals understand what makes them stand out, their desired image, and how they aim to achieve it.
Implicitly or explicitly all competing businesses employ a strategy to select a mix
of marketing resources. Formulating such competitive strategies fundamentally
involves recognizing relationships between elements of the marketing mix (e.g.,
price and product quality), as well as assessing competitive and market conditions
(i.e., industry structure in the language of economics).
Unveiling the Secrets How Does Generative AI Work.pdfSam H
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2. OBJECTIVES
Learn the processes involved in drug discovery and development
Define the phases involved in FDA drug approval
be aware of why/how new drugs are discovered
know the processes involved in drug discovery and development
see where pharmacologists/bioscientists may contribute
know about the difficulties and dangers inherent in the drug development
process.
WOLYITA UNIVERSITY DEPT. OF
PHARMACY
3. A substance used in the diagnosis, treatment, or prevention
of a disease or as a component of a medication recognized
or defined by the U.S. Food, Drug, and Cosmetic Act.
A drug is any chemical or biological substance, synthetic or
non-synthetic that can alter the structure and function of an
organism.
09/07/2007 DEPT. OF PHARMACEUTICS 3
drug
Introduction
4. The discovery and development of new medicines is along,
complicated process. Each success is built on many, many
prior failures.
Advances in understanding human biology and disease are
opening up exciting new possibilities for break through
medicines. At the same time, researchers face great
challenges in understanding and applying These advances
to the treatment of disease.
These possibilities will grow as our scientific knowledge
expands and becomes increasingly complex. Research-
based pharmaceutical companies are committed to
advancing science and bringing in new medicines to patients
5. THE CHANGED CONTEXT
OF DRUG DISCOVERY
AND DEVELOPMENT
The 1800s: natural sources; limited possibilities;
prepared by individuals; small scale; not purified,
standardized or tested; limited administration; no
controls; no idea of mechanisms.
The 1990s: synthetic source; unlimited possibilities;
prepared by companies; massive scale; highly
purified, standardized and tested; world-wide
administration; tight legislative control; mechanisms
partly understood.
7. DRUG
DISCOVERY/DEVELOPME
NT PROCESS
discovery; refinement; chemical & biological
characterisation
safety & toxicity in animals; formulation development
volunteer studies; patient studies regulatory process
marketing
post registration
monitoring
lessons
&
development
Discovery=find new active structure : Development=convert it to a useful drug
8. RESEARCH 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
9. ROLE 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
10. PRECLINICAL STUDIES
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
11. IND
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)
12. CLINICAL 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
Phase 4: Continued comparative studies. Registration and
market introduction
13. PHASE 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
14. PHASE 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
15. PHASE 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
16. NDA
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
17. FDA 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”
18. FDA 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
19. PHASE 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