Dear Fellow, Pharmaceutical Scientists.
I am pleased to invite you all to the Bioequivalence and Bioavailability Sciences community webinar on June 13, 2024. We are fortunate that Dr. Divyen Shah of SimCyp UK agreed to speak about "Physiologically and Clinically relevant dissolution methodologies, application in PBPK modelling for safe space approach "
.Please plan on attending this interesting webinar and I request each one of you to circulate this announcement among your peer groups and interested colleagues.
Topic: Physiologically/Clinically relevant dissolution methodologies application in PBPK modelling for safe space approach
Date and Time: June 13, 2024, Time: 10.00-11.00 EDT (New York, USA)
Abstract:
The adoption of physiologically based pharmacokinetic (PBPK) modelling to uphold drug product quality attributes such as Critical Material attributes, Critical quality attributes, Critical process parameters, Critical formulation variables-are continually advancing area. The utilization of PBPK is on the rise, with the US-FDA underlining the importance of patient-centric quality standards and clinically relevant drug product specifications over time.
By delineating a bioequivalence (BE) safe space through PBPK modelling, we can establish mechanistic relationships between in vitro and in vivo data (IVIVE), enhancing our comprehension of absorption mechanisms and critical bioavailability attributes. PBPK serves as a crucial tool for constructing a safe space that aids in drug product development and lifecycle management. Utilization of mechanistic absorption model can also aid in translation from one population, e.g. healthy adults, to target populations (diseased, paediatric etc.).
This presentation dives into the practical use of Physiologically Based Pharmacokinetic (PBPK) modelling with Virtual Bioequivalence (VBE) in the field of biopharmaceutics. Real-world case studies will be presented.
Divyen Shah, Ph.D. is a Research Scientist-II at Certara UK Limited (Simcyp Division) with focus on absorption modelling of oral drug products. He is leading Virtual bioequivalence (VBE) Module along with contribution in IVIVC and Absorption projects. He is having about 12 years of experience in the field of Biopharmaceutics, Clinical execution of BABE studies, Module 5 review, responding to regulatory queries, suggesting alternative BE approaches for PSG and Formulation Development. His role further included possible Rx to OTC switch, identification of unmet need for new product portfolio, Formulation-analysis of nanoparticulate drug delivery system. Prior to joining Certara, he has worked in Biocon Pharma Limited; Perrigo Laboratories India Pvt Ltd., Intas Pharmaceuticals Ltd. and Cipla Ltd. He has a doctorate degree in the field of Pharmaceutical Sciences.
Mark your Calendars and join the webinar on June 13, 2024, using information given below.
AAPS 2024 June BEBAS Community Webinar
Jun 13, 2024, 10:00 – 11:30 AM (EST-USA, New York)
Please join my meeting from your computer, tablet or smartphone.
https://meet.goto.com/372255453
You can also dial in using your phone.
Access Code: 372-255-453
United States: +1 (646) 749-3122
Join from a video-conferencing room or system.
Meeting ID: 372-255-453
Dial in or type: 67.217.95.2 or inroomlink.goto.com
Or dial directly: [email protected] or 67.217.95.2##372255453
Get the app now and be ready when your first meeting starts: https://meet.goto.com/install
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Prasad Tata M. Pharm, Ph.D., FCP
Sr. Director-PK/BE
American Regent, Inc.
East Windsor NJ
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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