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CENTER FOR DRUG EVALUATION AND
RESEARCHAPPLICATION NUMBER:202344Orig1s000CLINICAL PHARMACOLOGY AND
BIOPHARMACEUTICS REVIEW(S)OFFICE OF CLINICAL PHARMACOLOGY ADDENDUM
NDA : 202344Submission Date(s):
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What is office of clinical pharmacology?
The Office of Clinical Pharmacology is responsible for overseeing the clinical pharmacology and biopharmaceutics aspects of drug development and regulation.
Who is required to file office of clinical pharmacology?
Drug sponsors and applicants are required to file the Office of Clinical Pharmacology.
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The Office of Clinical Pharmacology form can be filled out online or submitted via mail with all the required information pertaining to drug development.
What is the purpose of office of clinical pharmacology?
The purpose of the Office of Clinical Pharmacology is to ensure the safety and effectiveness of drugs through the monitoring and regulation of clinical pharmacology aspects.
What information must be reported on office of clinical pharmacology?
Information such as pharmacokinetics, pharmacodynamics, drug interactions, and bioequivalence must be reported on the Office of Clinical Pharmacology.
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