Statistics on BCS Classification of Generic Drug Products Approved Between 2000 and 2011 in the USA Journal title: The AAPS Journal Authors: Anil K. Nair, Om Anand, Nam Chun, Dale P. Conner, Mehul U. Mehta, Duong T. Nhu, James E. Polli, Lawr... Subject(s): Medicine
Dissolution Testing for Generic Drugs: An FDA Perspective Journal title: The AAPS Journal Authors: Om Anand, Lawrence X. Yu, Dale P. Conner, Barbara M. Davit Subject(s): Medicine
A History of Biopharmaceutics in the Food and Drug Administration 1968–1993 Journal title: The AAPS Journal Authors: Jerome Philip Skelly Subject(s): Medicine
Comparison of Drug Permeabilities and BCS Classification: Three Lipid-Component PAMPA System Method versus Caco-2 Monolayers Journal title: The AAPS Journal Authors: Zeynep S. Teksin, Paul R. Seo, James E. Polli Subject(s): Medicine
Meeting Report: Applied Biopharmaceutics and Quality by Design for Dissolution/Release Specification Setting: Product Quality for Patient Benefit Journal title: The AAPS Journal Authors: Arzu Selen, Maria T. Cruañes, Anette Müllertz, Paul A. Dickinson, Jack A. Cook, Jame... Subject(s): Medicine
Antidrug Antibody Assay Validation: Industry Survey Results Journal title: The AAPS Journal Authors: Boris Gorovits Subject(s): Medicine
Role of Physiological Intestinal Water in Oral Absorption Journal title: The AAPS Journal Authors: Steven C. Sutton Subject(s): Medicine
Prediction of Solubility and Permeability Class Membership: Provisional BCS Classification of the World’s Top Oral Drugs Journal title: The AAPS Journal Authors: Arik Dahan, Jonathan M. Miller, Gordon L. Amidon Subject(s): Medicine
Use of the Biopharmaceutical Classification System in Early Drug Development Journal title: The AAPS Journal Authors: M. Sherry Ku Subject(s): Medicine
In Vitro Studies are Sometimes Better than Conventional Human Pharmacokinetic In Vivo Studies in Assessing Bioequivalence of Immediate-Release Solid Oral Dosage Forms Journal title: The AAPS Journal Authors: James E. Polli Subject(s): Medicine
Scientific Perspectives on Extending the Provision for Waivers of In vivo Bioavailability and Bioequivalence Studies for Drug Products Containing High Solubility-Low Permeability Drugs (BCS-Class 3) Journal title: The AAPS Journal Authors: Salomon Stavchansky Subject(s): Medicine
Summary Workshop Report: Bioequivalence, Biopharmaceutics Classification System, and Beyond Journal title: The AAPS Journal Authors: James E. Polli, Bertil S. I. Abrahamsson, Lawrence X. Yu, Gordon L. Amidon, John M. Baldoni, Jack A.... Subject(s): Medicine
Clinical Relevance of Dissolution Testing in Quality by Design Journal title: The AAPS Journal Authors: Paul A. Dickinson, Wang Wang Lee, Paul W. Stott, Andy I. Townsend, John P. Smart, Parviz Ghahramani,... Subject(s): Medicine
G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS Journal title: The AAPS Journal Authors: Vinod P. Shah, Gordon L. Amidon Subject(s): Medicine
Permeability classification of representative fluoroquinolones by a cell culture method Journal title: The AAPS Journal Authors: Donna A. Volpe Subject(s): Medicine