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CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 203491Orig1s000 CLINICAL PHARMACOLOGY AND BIOPHARMACEUTICS REVIEW(S) OND QA (Biopharmaceutics) Review 505(b)(2) NDA Applicant: Trademark:
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What is clinical pharmacology and?
Clinical pharmacology is the study of drugs and their effects on living organisms.
Who is required to file clinical pharmacology and?
Clinical pharmacology filings are typically required by pharmaceutical companies and researchers conducting clinical trials.
How to fill out clinical pharmacology and?
Clinical pharmacology forms are typically filled out electronically or submitted through specific regulatory portals.
What is the purpose of clinical pharmacology and?
The purpose of clinical pharmacology is to evaluate the safety and efficacy of drugs in humans.
What information must be reported on clinical pharmacology and?
Information such as drug dosages, frequency of administration, adverse reactions, and study results must be reported on clinical pharmacology forms.
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