clinical trials for product developement

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