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CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:202497Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S)OND QA BIOPHARMACEUTICS REVIEW NDA 505 (b)(2): Submission Date: Brand
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The Office of New Drugs Quality Assessment (ONDQA) Biopharmaceutics Review is a comprehensive evaluation of the biopharmaceutical aspects of a drug product.
The pharmaceutical company that is seeking approval for a new drug product or for changes to an existing drug product is required to file the ONDQA Biopharmaceutics Review.
The ONDQA Biopharmaceutics Review should be filled out by following the specific guidelines provided by the FDA and submitting all relevant data and information.
The purpose of the ONDQA Biopharmaceutics Review is to assess the biopharmaceutical properties of a drug product, including its pharmacokinetics, bioavailability, and formulation.
The ONDQA Biopharmaceutics Review must include data on the drug's composition, manufacturing process, stability, and performance in preclinical and clinical studies.
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