Clinical Pharmacology Review of Plasma-derived and Recombinant Protein Products: CBER Experience and Perspectives on Model-Informed Drug Development.

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Abstract

Clinical pharmacology studies are one of the major types of regulatory data submitted for review of therapeutic proteins regulated by the Center for Biologics Evaluation and Research (CBER).

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Author and article information

Journal

Journal ID (iso-abbrev): Haemophilia

Title: Haemophilia : the official journal of the World Federation of Hemophilia

Publisher: Wiley

ISSN (Electronic): 1365-2516

ISSN (Print): 1351-8216

Publication date (Electronic): Jul 2019

Volume: 25

Issue: 4

Affiliations

[1 ] Office of Biostatistics & Epidemiology, Center for Biologics Evaluation and Research, Food & Drug Administration, Silver Spring, Maryland.

[2 ] Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissue and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research, Food & Drug Administration, Silver Spring, Maryland.