Application of Mechanistic Ocular Absorption Modeling and Simulation to Understand the Impact of Formulation Properties on Ophthalmic Bioavailability in Rabbits: a Case Study Using Dexamethasone Suspension

Author:

Le Merdy Maxime,Fan Jianghong,Bolger Michael B.,Lukacova Viera,Spires Jessica,Tsakalozou Eleftheria,Patel Vikram,Xu Lin,Stewart Sharron,Chockalingam Ashok,Narayanasamy Suresh,Rouse Rodney,Matta Murali,Babiskin Andrew,Kozak Darby,Choi Stephanie,Zhang Lei,Lionberger Robert,Zhao Liang

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference41 articles.

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2. US. FDA. Bioavailability and bioequivalence studies for orally administered drug products—general considerations [Internet]. 2003. Available from: https://www.fda.gov/media/87219/download . Accessed 30 Apr 2019.

3. Choi SH, Lionberger RA. Clinical, pharmacokinetic, and in vitro studies to support bioequivalence of ophthalmic drug products. AAPS J. 2016;18(4):1032–8. https://doi.org/10.1208/s12248-016-9932-z .

4. Orange book: approved drug products with therapeutic equivalence evaluations [Internet]. [cited 2018 Dec 14]. Available from: https://www.accessdata.fda.gov/scripts/cder/ob/ . Accessed 30 Apr 2019.

5. Ali Y, Lehmussaari K. Industrial perspective in ocular drug delivery. Adv Drug Deliv Rev. 2006 Nov 15;58(11):1258–68.

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