Whether considering next steps following lead candidate selection, formulation optimization during Phase 1, 2, or 3, the likely impact of proposed post-marketing changes in product formulation or manufacture, or attempting to generate generic versions of an approved marketed drug product, an understanding of the critical factors influencing drug product absorption is essential . Such information also helps determine the method to be used for testing product in vitro drug release and the associated criteria for ensuring consistent batch-to-batch product performance.
There is a shared need among pharmaceutical scientists to identify the rate limiting factors influencing in vivo drug product performance from the perspective of its in vivo dissolution and absorption or its ability to ensure the availability of dissolved drug at a specific local site. These processes ultimately define the attributes critical to achieving some targeted in vivo drug exposure.
USP is convening a workshop where experts from a range of perspectives can meet and discuss new tools, opportunities, and strategies to assess and optimize in vivo drug product performance.
The workshop is divided into two one-day topics:
Day 1: Focuses on oral drug absorption and the translation of oral bioavailability predictions between humans and dogs. This topic will be considered from the perspective of in vitro, in vivo and in silico interspecies extrapolation.
Day 2: Focuses on in vitro and in silico assessments, opportunities, strengths and challenges. This topic will be explored from the perspective of the ability to predict target site drug delivery (gastrointestinal tract, skin, opthalmic products and lungs).
Following each morning and afternoon session, a moderated discussion will provide the opportunity to pose questions to the experts and to debate issues critical to the topics being discussed. For more information on the topics to be covered, please see the attached agenda.
- Sid Bhoopathy, Ph.D., Absorption Systems
- Sara Carlert, Ph.D., AstraZeneca
- Murat Cirit, Ph.D., Massachusetts Institute of Technology (MIT)
- Ayman El-Kattan, Ph.D., The University of Rhode Island, College of Pharmacy
- Raafat Fahmy, Ph.D., U.S. FDA Center for Veterinary Medicine
- Talia Flanagan, Ph.D., AstraZeneca
- Ben Forbes, Ph.D., Kings College London
- Masoud Jamei, Ph.D., Simcyp Limited (a Certara Company)
- Mansoor Khan, Ph.D., Texas A&M University-College Station
- Viera Lukacova, Ph.D., Simulations Plus, Inc.
- Marilyn Martinez, Ph.D., USP Expert Panel, Solubility Criteria for Veterinary Drugs
- Jonathan Mochel, DVM, MSc, Ph.D., Iowa State University
- Devendra Pade, Ph.D., Simcyp Limited (a Certara Company)
- Xavier Pepin, Ph.D., AstraZeneca
- Christos Reppas, Ph.D., National and Kapodistrian University of Athens
- Patrick Sinko, Rutgers University
- David Sperry, Eli Lilly and Company
- Konstantin Tsinman, Ph.D., Pion, Inc.
- Maria Vertzoni, Ph.D., National and Kapodistrian University of Athens