A Provisional Biopharmaceutical Classification of the Top 200 Oral Drug Products in the United States, Great Britain, Spain, and Japan-Reference-Cited by-同舟云学术

A Provisional Biopharmaceutical Classification of the Top 200 Oral Drug Products in the United States, Great Britain, Spain, and Japan

Published:2006-10-03 Issue:6 Volume:3 Page:631-643
ISSN:1543-8384
Container-title:Molecular Pharmaceutics
language:en
Short-container-title:Mol. Pharmaceutics

Author:

Takagi Toshihide¹,Ramachandran Chandrasekharan¹,Bermejo Marival¹,Yamashita Shinji¹,Yu Lawrence X.¹,Amidon Gordon L.¹

Affiliation:

1. College of Pharmacy, University of Michigan, Ann Arbor, Michigan 48109-1065, Department of Pharmacy and Technology, University of Valencia, Valencia, Spain, Faculty of Pharmaceutical Sciences, Setsunan University, Osaka, Japan, and Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland 20857

Publisher

American Chemical Society (ACS)

Subject

Drug Discovery,Pharmaceutical Science,Molecular Medicine

Link

https://pubs.acs.org/doi/pdf/10.1021/mp0600182

Reference54 articles.

1. Waiver of In Vivo Bioavailability and Bioequivalence Studies forImmediate-Release Solid Oral Dosage Forms Based on a BiopharmaceuticsClassification System; FDA Guidance for Industry; Federal Drug and Food Administration: Rockville, MD, 2002.

2. The biopharmaceutics classification system (BCS): Class III drugs — better candidates for BA/BE waiver?

3. Summary workshop report: Biopharmaceutics classification system—implementation challenges and extension opportunities

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