Clincal Trial Phases Final
Clincal Trial Phases Final
Clincal Trial Phases Final
Discovery
Chemistry
Discovery Target Assay Animal models of disease
Biology identificati develop-
on ment and
screening
IND NDA
LIFE CYCLE OF DRUG DISCOVERY,
DEVELOPMENT
Drug discovery & APPROVAL
Drug development Post-
(2-5 years) (5-9 years) approval
regulation
Each phase:
Cumulatively exposes greater numbers of
human subjects to the drug
Collects increasing amounts of safety and
efficacy data
Human Pharmacology or Phase I
Clinical trials
b=0.67
Maximum Recommended Starting Dose
(MRSD)
Margin of safety = HED x safety factor
(=10)
Differences in toxicity in animals
Unexpected toxicities
Interspecies difference in ADME
Differences in receptor densities or affinities
MRSD
Phase I Clinical trials
Determination of primary
efficacy parameter
Clinical endpoint
Surrogate
Clinical and Surrogate Endpoints
A. Phase II a
Pilot clinical trial
B. Phase II b
Pivotal clinical trial
PHASE II a
PILOT CLINICAL TRIAL
Feasibility trial
Small scale
Often un-blind and open label
Intended to provide experience to
investigator
PILOT CLINICAL TRIAL
OBJECTIVES
To confirm that trial medicine, procedure
are safe, suitable, and operational.
Dose range of new drug
Initial efficacy evaluation of a new drug,
or for new indication
Determine the duration required
PILOT CLINICAL TRIAL
OBJECTIVES 2
End points :
- Dynamic (primary and surrogate)
- Kinetic
- Biochemical
- Histological
Pharmaceutical Industry
Government organizations
International Agencies
Phase IV…characterstics
Expensive
Self-medication common
Types of Phase IV studies
Prospective studies :
- Extension of Phase III
(Longer drug treatment )
- Promotional Trials
Observational studies:
4. Pharmacoeconomic Studies