Hanan Ghantous covers the role and responsibilities of the pharmacology/toxicology reviewer related to the various components of the Investigational New Drug (IND) phase of drug development. This presentation covers both scientific and regulatory pharmacology/toxicology concepts that are part of the non-clinical submission to an IND/ NDA/BLA. Viewers will gain an understanding of animal studies submitted to support the safety of clinical studies and marketing applications.
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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5 авг 2020
