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References for Public Meeting on Alternative In Vitro Bioequivalence Pathways

The following references will be used as a basis for discussion:

Kostewicz ES, Abrahamsson B, Brewster M, Brouwers J, Butler J, Carlert S, Dickinson PA, Dressman J, Holm R, Klein S, Mann J, McAllister M, Minekus M, Muenster U, Müllertz A, Verwei M, Vertzoni M14, Weitschies W, Augustijns P. In Vitro Models for the Prediction of In Vivo Performance of Oral Dosage Forms. Eur J Pharm Sci. 2014 Jun 16; 57:342-66. doi: 10.1016/j.ejps.2013.08.024. Epub 2013 Aug 27.

Krishnaiah YS, Xu X, Rahman Z, Yang Y, Katragadda U, Lionberger R, Peters JR, Uhl K, Khan MA. Development of Performance Matrix for Generic Product Equivalence of Acyclovir Topical Creams. Int J Pharm. 2014 Nov 20;475(1-2):110-22. doi: 10.1016/j.ijpharm.2014.07.034. Epub 2014 Jul 30.

Martinez MN, Fahmy R. Demonstrating Comparative In Vitro Bioequivalence for Animal Drug Products Through Chemistry and Manufacturing Controls and Physicochemical Characterization: A Proposal. AAPS J. 2015 Jan 22. [Epub ahead of print] PubMed PMID: 25609223.

Phillips DJ, Pygall SR, Cooper VB, Mann JC. Overcoming Sink Limitations in Dissolution Testing: A Review of Traditional Methods and the Potential Utility of Biphasic Systems. J Pharm Pharmacol. 2012 Nov;64(11):1549-59. doi: 10.1111/j.2042-7158.2012.01523.x. Epub 2012 Apr 25.

Rahman Z, Xu X, Katragadda U, Krishnaiah YS, Yu L, Khan MA. Quality by Design Approach for Understanding the Critical Quality Attributes of Cyclosporine Ophthalmic Emulsion. Mol Pharm. 2014 Mar 3;11(3):787-99. doi: 10.1021/mp400484g. Epub 2014 Jan 24.

Yu LX. Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control. Pharm Res. 2008 Apr;25(4):781-91. doi: 10.1007/s11095-007-9511-1. Epub 2008 Jan 10.


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