Physiologically based Oral Absorption Modeling in Formulation Development and Regulatory Application
Amitava Mitra, Ph.D. (Sandoz)
The Physiologically Based Pharmacokinetic (PBPK) Modeling is a widely-used in silico tool in the pharmaceutical industry to predict oral drug absorption rate and extent, to simulate clinical pharmacokinetic profiles and also to support Regulatory submissions. Such models can provide valuable insights to address various aspects of challenges in the biopharmaceutics area. In vitro dissolution data are key inputs in these models to guide formulations development and also to assess if formulations would be bioequivalent. In this session, selected cases of the application of PBPK modeling will be discussed with the focus on guiding formulation development efforts, including drug-drug interactions (DDIs) with acid-reducing agents, evaluation of API PSD on formulation bioperformance of a BCS class-2 drug, solid dispersion formulation bioperformance, prediction of bioequivalence for IR and CR formulations and specification justification to the regulatory agencies.
Date and Location
Thurs Feb 21st, 2019
Registration & social hour: 5:30 PM
Hanover Marriott1401 Rt 10 E, Whippany, NJ 07981
About the speaker
Amitava Mitra currently works in Clinical Development at Sandoz, he has previously worked in the Biopharmaceutics group at Merck & Co. Amitava graduated with a PhD in Pharmaceutical Sciences from University of Maryland, Baltimore in 2006.
Amitava’s main research interests include pharmacokinetics, biopharmaceutics, PBPK modeling & simulation of oral and alternate drug delivery systems and IVIVC. He has interacted with global regulatory authorities on these topics. Amitava has published more than 40 research and review articles in peer-reviewed journals and has also authored book chapters on the topics of modeling & simulation, oral and alternate drug delivery, fixed dose combinations, and general biopharmaceutics. He has 20 podium presentations in national & international conferences. Amitava has been previously involved in cross-organization (industry, academia and regulatory) consortium, OrBiTo, which are related to development and improvement of analytical and computational tools.
Amitava is currently the Leader of AAPS Oral Biopharmaceutics and Absorption Modeling community, member of the AAPS Year-round Theme Task Force on Predictive Modeling and Clinical Pharmacology Track Chair on 2019 AAPS PharmSci 360 Scientific Programming Committee.
Registered and paid online: $50.00
Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY): $45.00
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