The document outlines the multi-step process for new drug development from research and discovery through clinical trials and regulatory approval. It involves early research, preclinical testing in labs and animals, and four phases of clinical trials in humans to test safety, efficacy, and get regulatory clearance. Phase 1 trials test safety in a small group, Phase 2 expands to test biological activity and potential efficacy, and Phase 3 tests therapeutic effects in large trials to confirm efficacy and comparative effectiveness for regulatory approval and launch.

1. NEW DRUG
DEVELOPMENT

2. DRUG
A substance intended for use in the diagnosis, cure,
mitigation (Reduction of pain), treatment, or prevention of
disease.

3. New Drug Development
Process
Research
Early
Developmen
t
Full
Developmen
t
Life Cycle
Managemen
t
Discovery
Phase
Candidat
e
Profiling
Phase
Preclinica
l Trials
Clinical
Trial
Phase I
Phase
IIA
Phase
IIB
Phase III
Phase
IV
CandidateSelection
Point
SelectedforProofof
Concept
Development
DecisionPoint
FullDevelopment
Point
PhaseIIICheckPoint
SubmissionDecision
Point
IND NDA
R&D
•Research Target
•Discovery of Lead
Compound
•Selection of
Suitable Candidate
Preclinical
•Lab testing
•Animal Studies
•Toxicology Studies
etc.,.
Clinical(I &
II)
•Biological Tests
and
Pharmacological
test in humans
•Regulatory
Clearance
Clinical
(III&IV)
•Registration with
Health Authorities
•Preparation for
Launch
•Launch and Sales
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4. Clinical Research -
Phases
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5. Phases of CR/CT

6. •Phase-0 ( Microdosing/IND study) [Preclinical data as it is to Human volunteer]
•Phase-1 ( Safety/Dose finding Phase)
•Phase-2 ( Biological Activity/ Potential efficacy finding phase)
•Phase-3 ( Therapeutic confirmatory/ comparative phase)
Phase-4 ( Post marketing surveillance/PV)
OVERVIEW

7. CONSIDERATIONS BEFORE STARTING PHASES

8. What is Phase-1?

10. Why?

11. Aims & Objectives?

12. Types?
Based on Dosing technique
Phase-1 A: Healthy subjects
Phase-1B: Diseased subject/ patients’ failure on the
conventional therapy

13. Documents required?

14. What is Phase-2?

15. Why?

16. Aims & Objectives?

17. Types?
Phase 2 A: pilot phase
Phase 2 B: pivotal phase

18. What is Phase-3?

19. Why?

20. Aims & Objectives?

21. Documents required?

22. PLACEBO