PHASES OF CLINICAL TRIALS

 

PHARM D 

V YEAR NOTES

CLINICAL RESEARCH

2. Clinical development of drug: 

PHASES OF CLINICAL TRIALS

Pharm D notes

Clinical trial is a systematic investigation in human subjects for evaluating the safety &

efficacy of any new drug.

Clinical trials are a set of tests in medical research and drug development that generate safety

and efficacy data for health interventions in human beings.

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

1. Preclinical (animal) testing.

2. An investigational new drug application (IND): outlines what the sponsor of a new drug

proposes for human testing in clinical trials.

3. Phase 1 studies 4. Phase 2 studies

5. Phase 3 studies

6. Submission of New Drug Application (NDA) is the formal step asking the FDA to consider

a drug for marketing approval.

7. FDA reviewers will approve the application or find it either "approvable" or "not

approvable."

8. Phase 4 studies

DRUG REVIEW

Before one can initiate testing in human beings, extensive pre- clinical or laboratory research

is required Research usually involves years of experiments in animal and human cells. If this

stage of testing is successful, the sponsor then provides this data to the FDA requesting

approval to begin testing in humans. This is called an Investigational New Drug (IND)

Application.

If approved by the FDA, testing in humans begins. This is done through a formally written

and approved protocol.

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PHASES OF CLINICAL TRIALS