BCS Biowaivers: Similarities and Differences Among EMA, FDA, and WHO Requirements Journal title: The AAPS Journal Authors: Barbara M. Davit, Isadore Kanfer, Yu Chung Tsang, Jean-Michel Cardot Subject(s): Medicine
Drug Discovery and Regulatory Considerations for Improving In Silico and In Vitro Predictions that Use Caco-2 as a Surrogate for Human Intestinal Permeability Measurements Journal title: The AAPS Journal Authors: Caroline A. Larregieu, Leslie Z. Benet Subject(s): Medicine
International Guidelines for Bioequivalence of Systemically Available Orally Administered Generic Drug Products: A Survey of Similarities and Differences Journal title: The AAPS Journal Authors: Barbara Davit, April C. Braddy, Dale P. Conner, Lawrence X. Yu Subject(s): Medicine
Toward Global Standards for Comparator Pharmaceutical Products: Case Studies of Amoxicillin, Metronidazole, and Zidovudine in the Americas Journal title: The AAPS Journal Authors: Raimar Löbenberg, Nadia B. Chacra, Erika S. Stippler, Vinod P. Shah, Anthony J. DeStefano, W... Subject(s): Medicine
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
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
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
Permeability classification of representative fluoroquinolones by a cell culture method Journal title: The AAPS Journal Authors: Donna A. Volpe Subject(s): Medicine
Biopharmaceutics Classification System-Based Biowaivers for Generic Oncology Drug Products: Case Studies Journal title: AAPS PharmSciTech Authors: Nilufer Tampal, Haritha Mandula, Hongling Zhang, Bing V. Li, Hoainhon Nguyen, Dale P. Conner Subject(s): Medicine
Considerations for a Pediatric Biopharmaceutics Classification System (BCS): Application to Five Drugs Journal title: AAPS PharmSciTech Authors: Shivani V. Gandhi, William Rodriguez, Mansoor Khan, James E. Polli Subject(s): Medicine
