Impact of Biopharmaceutics Classification System-Based Biowaivers-Reference-Cited by-同舟云学术

Impact of Biopharmaceutics Classification System-Based Biowaivers

Published:2010-09-07 Issue:5 Volume:7 Page:1539-1544
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Cook Jack A.¹,Davit Barbara M.¹,Polli James E.¹

Affiliation:

1. Department of Clinical Pharmacology, Specialty Care Business Unit, Pfizer Inc., New London, Connecticut, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland, and Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, 20 Penn Street, Baltimore, Maryland 21201

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/mp1001747

Reference26 articles.

1. An Industrial Implementation of the Biopharmaceutics Classification System

2. Feasibility of Biowaiver Extension to Biopharmaceutics Classification System Class III Drug Products

3. Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond

4. Anonymous. “Annex 7: Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability”. InWHO Expert Committee on Specifications for Pharmaceutical Preparations: Fortieth Report;WHO:Geneva, Switzerland, 2006; pp347−390.http://whqlibdoc.who.int/trs/WHO_TRS_937_eng.pdf(accessed March 19, 2010).

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