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.

1. Drug Development Process - an Overview
Tulsi Patil
M. PHARMA.(Pharmacology)
SSRCP

2. Objectives
• To Learn the process involved in drug discovery.
• To Learn the process involved in drug development.
• To Define the phases of clinical trials.
• To Explain the Role of FDA in the drug development and review
process.

3. Drug Development Process : Overview
• It is the process of bringing new drug to the market once a lead compound
has been identified through process of drug discovery.
1.Discovery and
development
2.Preclinical Research
3.Clinical
Research
4.INDA for FDA
Review
5. Post-Market Drug
Safety Monitoring

4. Drug discovery process
• Process by which pharmaceutical, biotechnology ,academic and Govt. labs
identify or screen compounds to find potentially active therapeutic agent.
Target
identification
Target
validation
Screening
Lead
identification
Lead
optimization
Therapeutic
concept
Potential
candidate

5. Drug Development Process
• Once the new chemical entity is discovered it has to be subjected to the
development process.
• It can be divided into : 1. Preclinical pharmacology
2. Clinical pharmacology
1. Preclinical pharmacology:
It is the identification of toxicity and Pharmacology of the drug into the
animal models.

6. Cont..

7. Phases of clinical trial.
1. Phase 0 : It is a recent designation according to the United States Food
and Drug Administration's (FDA) 2006 Guidance
• Phase 0 trials are also known as human microdosing studies.
• Dose: subtherapeutic dose
• Objective :to obtain pharmacokinetic data.
• Phase 0 clinical trial are not mandatory. They are case to case based

8. 2. Phase I :
• Phase I trials are the first stage of testing in human subjects. Normally, a
small group of 20–100 healthy volunteers will be recruited.
• Primary goal: To assess the safety (pharmacovigilance),
tolerability,(Maximum toleratedble dose)pharmacokinetics, and
pharmacodynamis of a drug.
3. Phase II:
• Once a dose or range of doses is determined, the next goal is to evaluate
whether the drug has any biological activity or effect.
• Phase II trials are performed on larger groups (100-300) and are designed
to assess how well the drug works(efficacy).
Cont..

9. 4. Phase III :
• Phase III of a clinical trial usually involves up to 3,000 patient groups or more
depending upon the disease/medical condition studied.
• Trials in this phase can last for several years.
• The purpose of phase III is to evaluate how the new medication works in
comparison to existing medications for the same condition.
• Phase III trials are usually double-blind, which means that neither the participant
nor the investigator knows which medication the participant is taking. This helps
to eliminate bias when interpreting results.
5. Phase IV:
• Phase IV clinical trials happen after the FDA has approved medication. This phase
involves thousands of participants and can last for many years.
• Investigators use this phase to get more information about the medication’s long-
term safety, effectiveness, and any other benefits.
Cont..

10. IND (Investigational New Drug)
• An Investigation New Drug Application (IND) is a submission to Food &
Drug Administration (FDA) requesting permission to initiate the study of
New drug product.
• The FDA reviews the IND application for safety to assure that research
subjects will not be subjected to unreasonable risk.
• If the application is approved, the candidate drug usually enters a Phase 1
clinical trial .
• FDA has an opportunity to review the IND within 30 days

11. References
• https://www.ecfr.gov/cgi-bin/ECFR?page=browse
• Russell Katz, The introduction of new drugs,USP,Ch no: 48,Pg no: 932-941.
• Catalyst Clinical Services”Drug regulatory affairs”pg no.4-15
• Douglas J. Pisano, David S. Manlus –FDA Regulatory Affairs, “A guide for
Prescription Drugs, Medical Devices and Biologics-New drug Application”
,2 nd edition ,Marcel Dekker,inc , pg no: 69-108.
• http://www.fda.gov/cder/guidance/index.html