Physiologically based Oral Absorption Modeling in Formulation Development and Regulatory Application

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
Dinner & presentation: 6:30 PM

Meeting Sponsors

Croda


Hanover Marriott

1401 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.

Registration Fees

  • Registered and paid online:     $50.00
  • Walk-in:     $65.00
  • Between-positions, Retirees & Students (WITH ADVANCE REGISTRATION ONLY):     $45.00

Advance registration will end at 5:00 PM on WEDNESDAY FEB 20th;  after that, you must pay at the door.  Note also that if you choose the "Register and Pay at Meeting" option, you must proceed all the way to the "Your Order is Confirmed" screen or your registration will not be recorded.

Note: in the event a meeting needs to be cancelled due to weather or other conditions, NJPhAST will do its best to notify all registrants as soon as possible; however, we ask that you exercise individual judgement if you do not hear directly from NJPhAST.

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