Challenges and Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence of Modified Release Products: Workshop Summary Report Journal title: The AAPS Journal Authors: Mei-Ling Chen, Vinod P. Shah, Derek Ganes, Kamal K. Midha, James Caro, Prabu Nambiar, Mario L. Rocci... Subject(s): Medicine
An Investigation into the Importance of “Very Rapid Dissolution” Criteria for Drug Bioequivalence Demonstration using Gastrointestinal Simulation Technology Journal title: The AAPS Journal Authors: Ivan Kovačevi, Jelena Parojči, Marija Tubi-Grozdanis, Peter Langguth Subject(s): Medicine
In Vitro Considerations to Support Bioequivalence of Locally Acting Drugs in Dry Powder Inhalers for Lung Diseases Journal title: The AAPS Journal Authors: Sau Lawrence Lee, Wallace P. Adams, Bing V. Li, Dale P. Conner, Badrul A. Chowdhury, Lawrence X. Yu Subject(s): Medicine
Highly Variable Drugs: Observations from Bioequivalence Data Submitted to the FDA for New Generic Drug Applications Journal title: The AAPS Journal Authors: Barbara M. Davit, Dale P. Conner, Beth Fabian-Fritsch, Sam H. Haidar, Xiaojian Jiang, Devvrat T. Pat... Subject(s): Medicine
FDA Critical Path Initiatives: Opportunities for Generic Drug Development Journal title: The AAPS Journal Authors: Robert A. Lionberger Subject(s): Medicine
Application of Gastrointestinal Simulation for Extensions for Biowaivers of Highly Permeable Compounds Journal title: The AAPS Journal Authors: Marija Tubic-Grozdanis, Michael B. Bolger, Peter Langguth 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
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
