Professional Documents
Culture Documents
Submitted to:
Dr.AbuBakar Munir
CONTENTS
1. INTODUCTION
2. NEED OF DOSAGE FORM
3. PHASES OF PRODUCT FORMULATION
4. PRE CLINICAL TESTING
5. CLINICAL TRIALS
Introduction Pre-Discovery Discovery Pre-clinical Trials Clinical Trials
Disease
understandi
ng
PRE-
Identification
DISCOVERY of target
Validation of
target
Introduction Pre-Discovery Discovery Pre-clinical Trials Clinical Trials
biological target
demonstrate that
At molecular level Biological target
a molecular target
Gene changes for a potential
is directly involved
Affect of these new medicine is
in a disease
changes chosen
process
Introduction Pre-Discovery Discovery Pre-clinical Trials Clinical Trials
Optimize pharmacokinetics
Introduction Pre-Discovery Discovery Pre-clinical Trials Clinical Trials
Is compound
Is compound safe(non-toxic)
safe(non-toxic) in
in living
living organisms
organisms ??
E.g. Nerve
E.g. Nerve Damage-
Damage- Neurotoxin
Neurotoxin
Pre-Clinical Trials
CLINICAL TRIALS FDA
REVIEW
10,000
Compounds 250 1 FDA
Compounds 5 Compound Approved
Drug
1.5
6.5 Years 7 Years years
New chemical entity Pre-clinical studies IND
Source: natural, high Including chemistry, (Investigational
throughput screening, physical properties, new drug)
biotechnology, lead biological , pharmacology, application
optimization. ADME, toxicology. Submission
FDA review
Pre-clinical
studies
(continued)
Post New drug Long term animal
marketing: application toxicology, product
Phase IV Submission formulation
clinical trials FDA review
Toxicology Preapproval
Product defect plant
reporting Clinical trials
inspection
Phase I
Phase II
Phase III
Introduction Pre-Discovery Discovery Pre-clinical Trials Clinical Trials
Investigation New Drug Application (IND)
IND
Review by CDER
Pharmacology/
Medical Chemistry Toxicological
Statistical
Safety No
Clinical
acceptable for
hold
study to Notify Sponsor
Decision
proceed
Yes No
Complete Review
No Sponsor notified about
Review deficiencies
Acceptable
Yes
No Deficiencies Study on Going*
Phase 0
Phase 1
als
Phase 2
Tri
cal
Phase 3
ni
Cli
Phase 4
Phase 0 Phase 1 Phase 2 Phase 3 Phase 4
Up to several months
Phase 2 100-300
up to 2 years
up to 4 years
Continuous Evaluation
Any
question?