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CLINICAL TRIALS FOR PRODUCT DEVELOPEMENT
Speaker:MADIHA AHMED 11761BUSHRA KHAN 11742
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CLINICAL TRIALS :
A research activity that involves administration of a test treatment to some experimental unit in order to evaluate the treatment.
Clinical Trials
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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.
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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
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CPD-Phases
CLINICAL PRODUCT DEVELOPMENT- PHASES:
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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 :
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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 :
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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.
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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
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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
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Correlation