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International Journal of Pharmaceutics|August 2, 2011
The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluationWenlei Jiang, Stephanie Kim, Xinyuan Zhang, et al.
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.
The AAPS Journal|June 22, 2012
Statistics on BCS classification of generic drug products approved between 2000 and 2011 in the USAAnil K Nair, Om Anand, Nam Chun, et al.
The AAPS Journal|December 2, 2011
Common deficiencies with bioequivalence submissions in abbreviated new drug applications assessed by FDAQing Liu, Barbara M Davit, Svetlana A Cherstniakova, 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.
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|June 12, 2012
Summary workshop report: Facilitating oral product development and reducing regulatory burden through novel approaches to assess bioavailability/bioequivalenceJames E Polli, Jack A Cook, Barbara M Davit, et al.
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