Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage Forms Journal title: The AAPS Journal Authors: Zhongqiang Lin, Deliang Zhou, Stephen Hoag, Yihong Qiu Subject(s): Medicine
An Exact Procedure for the Evaluation of Reference-Scaled Average Bioequivalence Journal title: The AAPS Journal Authors: Laszlo Tothfalusi, Laszlo Endrenyi Subject(s): Medicine
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
Analytical Similarity Assessment in Biosimilar Studies Journal title: The AAPS Journal Authors: Shein-Chung Chow, Fuyu Song, He Bai Subject(s): Medicine
Survey of International Regulatory Bioequivalence Recommendations for Approval of Generic Topical Dermatological Drug Products Journal title: The AAPS Journal Authors: April C. Braddy, Barbara M. Davit, Ethan M. Stier, Dale P. Conner Subject(s): Medicine
Demonstrating Comparative In Vitro Bioequivalence for Animal Drug Products Through Chemistry and Manufacturing Controls and Physicochemical Characterization: A Proposal Journal title: The AAPS Journal Authors: Marilyn N. Martinez, Raafat Fahmy Subject(s): Medicine
Application of the Modified Chi-Square Ratio Statistic in a Stepwise Procedure for Cascade Impactor Equivalence Testing Journal title: The AAPS Journal Authors: Benjamin Weber, Sau L. Lee, Renishkumar Delvadia, Robert Lionberger, Bing V. Li, Yi Tsong, Guenther... Subject(s): Medicine
Reference Datasets for Bioequivalence Trials in a Two-Group Parallel Design Journal title: The AAPS Journal Authors: Anders Fuglsang, Helmut Schütz, Detlew Labes Subject(s): Medicine
International Guidelines for Bioequivalence of Locally Acting Orally Inhaled Drug Products: Similarities and Differences Journal title: The AAPS Journal Authors: Dongmei Lu, Sau L. Lee, Robert A. Lionberger, Stephanie Choi, Wallace Adams, Hoainhon N. Caramenico,... Subject(s): Medicine
Pilot and Repeat Trials as Development Tools Associated with Demonstration of Bioequivalence Journal title: The AAPS Journal Authors: Anders Fuglsang Subject(s): Medicine
In Vitro Testing for Orally Inhaled Products: Developments in Science-Based Regulatory Approaches Journal title: The AAPS Journal Authors: Ben Forbes, Per Bäckman, David Christopher, Myrna Dolovich, Bing V. Li, Beth Morgan Subject(s): Medicine
A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion Journal title: The AAPS Journal Authors: Wenlei Jiang, Fairouz Makhlouf, Donald J. Schuirmann, Xinyuan Zhang, Nan Zheng, Dale Conner, Lawrenc... Subject(s): Medicine
A Systematic Analysis of the Sensitivity of Plasma Pharmacokinetics to Detect Differences in the Pulmonary Performance of Inhaled Fluticasone Propionate Products Using a Model-Based Simulation Approach Journal title: The AAPS Journal Authors: Benjamin Weber, Guenther Hochhaus Subject(s): Medicine
On the Incorrect Statistical Calculations of the Kinetica Software Package in Imbalanced Designs Journal title: The AAPS Journal Authors: S. Morales-Alcelay, J. M. de la Torre de Alvarado, A. García-Arieta Subject(s): Medicine
Applications of In Vitro–In Vivo Correlations in Generic Drug Development: Case Studies Journal title: The AAPS Journal Authors: Paramjeet Kaur, Xiaojian Jiang, John Duan, Ethan Stier Subject(s): Medicine
