FDA Bioequivalence Standards (Hardcover, 2014)

.- 1 Bioequivalence History .- Alex Yu, Duxin Sun, Bing Li, and Lawrence X. Yu .- 2 Fundamentals of Bioequivalence .- Mei-Ling Chen .- 3 Basic Statistical Considerations .- Fairouz T. Makhlouf, Stella C. Grosser, Donald J. Schuirmann .- 4 The Effects of Food on Drug Bioavailability and Bioequivalence .- Wayne I. DeHaven and Dale P. Conner .- 5 Biowaiver and Biopharmaceutics Classification System .- Ramana S. Uppoor, Jayabharathi Vaidyanathan, Mehul Mehta, and Lawrence X. Yu .- 6 Bioequivalence of Highly Variable Drugs .- Barbara M. Davit and Devvrat T. Patel .- 7 Partial Area under the Curve: An Additional Pharmacokinetic Metric for Bioavailability and Bioequivalence Assessments .- Hao Zhu, Ramana Uppoor, Mehul Mehta, and Lawrence X. Yu .- 8 Bioequivalence for Narrow Therapeutic Index Drugs .- Wenlei Jiang and Lawrence X. Yu .- 9 Pharmacodynamic Endpoint-based Bioequivalence Studies .- Peng Zou and Lawrence X. Yu .- 10 Clinical Endpoint Bioequivalence Study .- John R Peters .- 11 Bioequivalence for Liposomal Drug Products .- Nan Zheng, Wenlei Jiang, Robert Lionberger, and Lawrence X. Yu .- 12 Bioequivalence for Drug Products Acting Locally within Gastrointestinal Tract .- Xiaojian Jiang,, Yongsheng Yang, and Ethan Stier .- 13 Bioequivalence for Topical Drug Products .- April C. Braddy and Dale P. Conner .- 14 Bioequivalence for Orally Inhaled and Nasal Drug Products .- Bhawana Saluja, Bing V. Li and Sau L. Lee .- 15 Bioequivalence: Modeling and Simulation .- Xinyuan Zhang and Robert Lionberger .- 16 Bioanalysis .- Sriram Subramaniam.