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
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
Evaluation of a Scaling Approach for the Bioequivalence of Highly Variable Drugs Journal title: The AAPS Journal Authors: Sam H. Haidar, Fairouz Makhlouf, Donald J. Schuirmann, Terry Hyslop, Barbara Davit, Dale Conner, Law... Subject(s): Medicine
Effect of Excipients on the Particle Size of Precipitated Pioglitazone in the Gastrointestinal Tract: Impact on Bioequivalence Journal title: The AAPS Journal Authors: Masaru Sugita, Makoto Kataoka, Masahisa Sugihara, Susumu Takeuchi, Shinji Yamashita Subject(s): Medicine
Statistical Comparison of Dissolution Profiles to Predict the Bioequivalence of Extended Release Formulations Journal title: The AAPS Journal Authors: J. D. Gomez-Mantilla, U. F. Schaefer, V. G. Casabo, T. Lehr, C. M. Lehr Subject(s): Medicine
A Sequential Bioequivalence Design with a Potential Ethical Advantage Journal title: The AAPS Journal Authors: Anders Fuglsang Subject(s): Medicine
Reference Datasets for 2-Treatment, 2-Sequence, 2-Period Bioequivalence Studies Journal title: The AAPS Journal Authors: Helmut Schütz, Detlew Labes, Anders Fuglsang Subject(s): Medicine
A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution Journal title: The AAPS Journal Authors: Benjamin Weber, Guenther Hochhaus, Wallace Adams, Robert Lionberger, Bing Li, Yi Tsong, Sau L. Lee Subject(s): Medicine
Common Reasons for “For-Cause” Inspections in Bioequivalence Studies Submitted to the Food and Drug Administration Journal title: The AAPS Journal Authors: Bing V. Li, Barbara M. Davit, Christina H. Lee, Santhosh K. Pabba, Chitra Mahadevan, Hoainhon T. Car... Subject(s): Medicine
Atenolol quantification in human plasma by high-performance liquid chromatography: Application to bioequivalence study Journal title: The AAPS Journal Authors: Luis Renato Pires de Abreu, Silvana Aparecida Calafatti de Castro, José Pedrazzoli Subject(s): Medicine
Influence of drug release properties of conventional solid dosage forms on the systemic exposure of highly soluble drugs Journal title: The AAPS Journal Authors: Lawrence X. Yu, Christopher D. Ellison, Dale P. Conner, Larry J. Lesko, Ajaz S. Hussain 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
Application of Absorption Modeling to Predict Bioequivalence Outcome of Two Batches of Etoricoxib Tablets Journal title: AAPS PharmSciTech Authors: Amitava Mitra, Filippos Kesisoglou, Peter Dogterom 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
