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The Annals of Pharmacotherapy|September 25, 2009
Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug AdministrationBarbara M Davit, Patrick E Nwakama, Gary J Buehler, et al.Pharmaceutical Research|September 25, 2007
Bioequivalence approaches for highly variable drugs and drug productsSam H Haidar, Barbara Davit, Mei-Ling Chen, et al.The AAPS Journal|May 1, 2008
Highly variable drugs: observations from bioequivalence data submitted to the FDA for new generic drug applicationsBarbara M Davit, Dale P Conner, Beth Fabian-Fritsch, et al.Journal of Pharmaceutical Sciences|September 17, 2015
Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and AcyclovirSoundarya Vaithianathan, Sam H Haidar, Xinyuan Zhang, et al.Journal of Pharmaceutical Sciences|March 30, 2016
Reply to "On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs"Soundarya Vaithianathan, Sam H Haidar, Xinyuan Zhang, et al.The AAPS Journal|October 12, 2012
Common reasons for "for-cause" inspections in bioequivalence studies submitted to the Food and Drug AdministrationBing V Li, Barbara M Davit, Christina H Lee, et al.The AAPS Journal|September 14, 2012
Implementation of a reference-scaled average bioequivalence approach for highly variable generic drug products by the US Food and Drug AdministrationBarbara M Davit, Mei-Ling Chen, Dale P Conner, et al.The AAPS Journal|January 1, 2015
Workshop report: Crystal City V--quantitative bioanalytical method validation and implementation: the 2013 revised FDA guidanceBrian Booth, Mark E Arnold, Binodh DeSilva, et al.Pageof 2