Drug regulatory affairs

1. Clinical Research Regulations
PG SEM I (MRA 103T)
Unit 1: Drug Development Process
Dimple Marathe
Assistant Professor
Sanjivani College of Pharmaceutical Education & Research
Kopargaon

2. Introduction. .
Clinical Trials
• An organised research study designed to investigate new methods of preventing,
detecting, diagnosing, or treating an illness or disease
• Clinical: Pertaining to humans (subjects volunteers, patients)
• Research: The study of material & sources in order to establish facts & reach new
conclusions (analysis, enquiry, examination, experimentation, exploration, fact-
finding, inquiry, investigation, probe, scrutiny, searching, study)

3. Introduction
Purpose of Clinical Trials
• Systematic study of new drug(s) in human subject(s)
• To generate data for discovering and/or verifying the clinical,
pharmacological (including pharmacodynamic and pharmacokinetic) and/or
adverse effects with the objective of determining safety and/or efficacy of the
new drug

4. Drug Development Process
• The entire process of taking a newly discovered compound or drug
through regulatory approval to the point of marketing
• During the development, the new drug or the compound should
adhere to high standards in the conduct, analysis and interpretation of
preclinical and clinical studies for its smooth passage through the
regulatory approval phase and eventually to marketing

5. Purpose of Drug Development
• To alleviate the signs and symptoms of new diseases
• To find therapeutic solutions for existing diseases

6. Drug Development Process Classification
• The process of drug development can be broadly classified as pre-clinical
and clinical trials
• Pre-clinical refers to experimentation that occurs before it is given to
human subjects (animals); whereas, clinical refers to experimentation with
humans. Within the realm of clinical research, clinical trials are classified
into four phases

7. Drug Development Process

8. Drug Development Process. .
Discovery/ Pre-
Clinical Testing
Phase I Phase II Phase III FDA Phase IV
Years 5 - 6.5
File at FDA
1.5 2 2.5
File
NDA
at
FDA
1.5- 2
15
Total
Test
Population
Laboratory & Animal
Studies
20 to 100
healthy
volunteers
100 to 500
patient
volunteers
1000 to 5000
patient
volunteers
Review &
Proposal
Process
Additional
Post-
Marketing
testing
required
by FDA
Purpose
Assess safety,
biological activity &
formulations
Determine
safety &
dosage
Evaluate
effectiveness,
look for side-
effects
Confirm
effectiveness
, monitor
adverse
effects from
long-time use
Success
Rate
5000 compounds
evaluated
5 Enter Trials
1
Approved
Source: Pharmaceutical Research & Manufacturers of America, www.pharma.org

9. References
• https://www.ich.org/page/efficacy-guidelines
• Rosenbaum.D,Dresser.M,chapter 1 : Phases Of Clinical Research,
Clinical Research coordinator Handbook GCP:Tools and
Techniques,2nd Edition 2002

10. Thank You