clinical trials for product developement
TRANSCRIPT
CLINICAL TRIALS FOR PRODUCT DEVELOPEMENT
Speaker:MADIHA AHMED 11761BUSHRA KHAN 11742
CLINICAL TRIALS :
A research activity that involves administration of a test treatment to some experimental unit in order to evaluate the treatment.
Clinical Trials
Clinical Trials
• Clinical trials are conducted only
when,
-Satisfactory information has been gathered
on the quality of the nonclinical safety.
- Health authority/ethics
committee approval is granted in the
country where approval of the drug is
sought.
• Clinical Trial is the mainstay for
bringing out New Drugs to the
Market.
Drug Review Steps
Preclinical (animal) testing. An investigational new drug application (IND) : outlines what the sponsor of a new drug proposes for human testing in clinical
trials. Phase 1 studies Phase 2 studies Phase 3 studies
Submission of New Drug Application (NDA) is the formal step asking the FDA to
consider a drug for marketing approval.FDA reviewers will approve the
application or find it either "approvable" or "not approvable.“ Phase 4 studies
DRUG REVIEW STEPS : Preclinical Data
IND Filing
IND Approval
Phase I
Phase II
Phase III
NDA Filed
NDA Approval
Marketing Permission
Phase IV
DCGI
Mandatory Approval Points
Sponsor
Go/No Go
Decision
Points
CPD-Phases
CLINICAL PRODUCT DEVELOPMENT- PHASES:
Clinical Trials
Major areas are:• Pharmacodynamic studies in vivo in animals, In vitro preparation• Absorption, distribution , elimination studies (pharmacokinetics)• Acute ,sub acute, chronic toxicity studies (toxicity profile)• Therapeutic index (safety & efficacy evaluation)
PRECLINICAL TRIAL :
Phases Of Clinical Trials
Focused on tolerability and safety. 12-30 (150) healthy people (often males). Efficacy on biomarkers . Single and repeated doses. Increase dose levels. Interaction with other drugs. Pharmacokinetics. Explorative.
Phase I50-150people
Phase II100-200people
Phase III500-15000people
Phase IV studies continue
PHASE 1 TRIAL :
Phases Of Clinical Trials
Phase I50-150people
Phase II100-200people
Phase III500-15000people
Phase IV studies continue
PHASE 2 TRIAL :
50-1000 patients. Extensive monitoring. Safety and tolerability in patients. Often complicated design, explorative. Selection of optimal dose. Pharmacokinetics in patients. Effect in special populations. Explorative.
Phases Of Clinical Trials
Phase I50-150people
Phase II100-200people
Phase III500-15000people
Phase IV studies continue
PHASE 3 TRIAL :
500-15000 patients Effect is verified in the target population Forms the basis of the NDA, New Drug Application Interactions between drugs start to become measurable in the larger population Sub-groups start to be established Special features and problems show up Confirmative
Phases Of Clinical Trials
Phase I50-150people
Phase II100-200people
Phase III500-15000people
Phase IV studies continue
PHASE 4 TRIAL :
Often large 500-15000 patients Further investigation of efficacy and safety post approval Special populations New indications Marketing
Correlation