This powerpoint presentation will help to know the introduction of Pre Clinical Trials.Hope you understand well.If you need more notes refer some pharma and Biotechnology books.
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.
Drug discovery is a
process which aims
at identifying a
compound
therapeutically useful
in curing and treating
disease
Target identification is process of
identifying the direct molecular
target(protein, nucleic acid, or
small molecule).
Identifying the biological of the
disease and the potential targets
for involvement ,is the first step in
the discovery of a medicine
This powerpoint presentation will help to know the introduction of Pre Clinical Trials.Hope you understand well.If you need more notes refer some pharma and Biotechnology books.
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.
Drug discovery is a
process which aims
at identifying a
compound
therapeutically useful
in curing and treating
disease
Target identification is process of
identifying the direct molecular
target(protein, nucleic acid, or
small molecule).
Identifying the biological of the
disease and the potential targets
for involvement ,is the first step in
the discovery of a medicine
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
In the slideshare i have discussed about principal of preclinical studies
various approaches towards preclinical studies
a route map of preclinical trials and its various methods
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
In the slideshare i have discussed about principal of preclinical studies
various approaches towards preclinical studies
a route map of preclinical trials and its various methods
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.
COVID-19 PCR tests remain a critical component of safe and responsible travel in 2024. They ensure compliance with international travel regulations, help detect and control the spread of new variants, protect vulnerable populations, and provide peace of mind. As we continue to navigate the complexities of global travel during the pandemic, PCR testing stands as a key measure to keep everyone safe and healthy. Whether you are planning a business trip, a family vacation, or an international adventure, incorporating PCR testing into your travel plans is a prudent and necessary step. Visit us at https://www.globaltravelclinics.com/
Global launch of the Healthy Ageing and Prevention Index 2nd wave – alongside...ILC- UK
The Healthy Ageing and Prevention Index is an online tool created by ILC that ranks countries on six metrics including, life span, health span, work span, income, environmental performance, and happiness. The Index helps us understand how well countries have adapted to longevity and inform decision makers on what must be done to maximise the economic benefits that comes with living well for longer.
Alongside the 77th World Health Assembly in Geneva on 28 May 2024, we launched the second version of our Index, allowing us to track progress and give new insights into what needs to be done to keep populations healthier for longer.
The speakers included:
Professor Orazio Schillaci, Minister of Health, Italy
Dr Hans Groth, Chairman of the Board, World Demographic & Ageing Forum
Professor Ilona Kickbusch, Founder and Chair, Global Health Centre, Geneva Graduate Institute and co-chair, World Health Summit Council
Dr Natasha Azzopardi Muscat, Director, Country Health Policies and Systems Division, World Health Organisation EURO
Dr Marta Lomazzi, Executive Manager, World Federation of Public Health Associations
Dr Shyam Bishen, Head, Centre for Health and Healthcare and Member of the Executive Committee, World Economic Forum
Dr Karin Tegmark Wisell, Director General, Public Health Agency of Sweden
The dimensions of healthcare quality refer to various attributes or aspects that define the standard of healthcare services. These dimensions are used to evaluate, measure, and improve the quality of care provided to patients. A comprehensive understanding of these dimensions ensures that healthcare systems can address various aspects of patient care effectively and holistically. Dimensions of Healthcare Quality and Performance of care include the following; Appropriateness, Availability, Competence, Continuity, Effectiveness, Efficiency, Efficacy, Prevention, Respect and Care, Safety as well as Timeliness.
This document is designed as an introductory to medical students,nursing students,midwives or other healthcare trainees to improve their understanding about how health system in Sri Lanka cares children health.
PET CT beginners Guide covers some of the underrepresented topics in PET CTMiadAlsulami
This lecture briefly covers some of the underrepresented topics in Molecular imaging with cases , such as:
- Primary pleural tumors and pleural metastases.
- Distinguishing between MPM and Talc Pleurodesis.
- Urological tumors.
- The role of FDG PET in NET.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
LGBTQ+ Adults: Unique Opportunities and Inclusive Approaches to CareVITASAuthor
This webinar helps clinicians understand the unique healthcare needs of the LGBTQ+ community, primarily in relation to end-of-life care. Topics include social and cultural background and challenges, healthcare disparities, advanced care planning, and strategies for reaching the community and improving quality of care.
Empowering ACOs: Leveraging Quality Management Tools for MIPS and BeyondHealth Catalyst
Join us as we delve into the crucial realm of quality reporting for MSSP (Medicare Shared Savings Program) Accountable Care Organizations (ACOs).
In this session, we will explore how a robust quality management solution can empower your organization to meet regulatory requirements and improve processes for MIPS reporting and internal quality programs. Learn how our MeasureAble application enables compliance and fosters continuous improvement.
2. Doug Brutlag 2011
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
4. Doug Brutlag 2011
The Discovery Process
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.
5. Doug Brutlag 2011
Find a Lead Compound
Identification of small molecule modulators of
protein function.
The process of transforming these into high
content lead series.
6. Doug Brutlag 2011
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, muta-
genicity and teratogenicity.
Efficacy studies on animals.
7. Doug Brutlag 2011
IND (Investigational New Drug)
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).
8. Doug Brutlag 2011
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.
New Drug Application (NDA): Regulatory review.
9. Doug Brutlag 2011
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.
10. Doug Brutlag 2011
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.
11. Doug Brutlag 2011
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.
12. Doug Brutlag 2011
NDA - 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.