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Evaluation of New Drugs and INDA Process by Keisha Dela Cerna is a document available to read on EtoBox.

What is Evaluation of New Drugs and INDA Process about?

The document outlines the process for developing and evaluating new drugs, which involves lengthy pre-clinical and clinical testing. Pre-clinical studies involve drug characterization, formulation, and animal/cell testing. If results are promising, an INDA allows clinical trials with human subjects. Clinical trials have 4 phases, with Phases 1-3 testing safety, efficacy, and side effects in increasing numbers of subjects. After Phase 3 demonstrates safety and efficacy, an NDA can be filed for FDA approval t

Author

Keisha Dela Cerna

Language

EN