HISTORY AND VARIOUS PHASES OF DRUG DEVELOPMENT AND DRUG APPROVAL PROCESS. Pool of Contents. History of drug development & drug approval process Various phases of drug development & drug approval process FDA’S Definitions of New Drug Treatment INDA References.
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HISTORY AND VARIOUS PHASES
OF DRUG DEVELOPMENT AND
DRUG APPROVAL PROCESS
Of the subjects and to ensure that the investigational plan is sound and is designed to achieve the stated objectives.
e.g.: AIDS ,advanced metastasis refractory cancers, advanced multiple sclerosis, bacterial endocarditis
??? Questions ????
DEFINE NEW DRUG AS PER FDA.
DISCUSS HISTORICAL BACK GROUND OF DRUG APPROVAL.
EXPLAIN THE BASIC DRUG APPROVAL PROCESS IN DETAIL.
EXPLAIN CLINICAL TRIALS IN BRIEF.
WHAT IS TREATMENT INDA?
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