I am proud to feature the work of AAPS Member James Polli, Ph.D., FAAPS, to further advance the science of physiologically based biopharmaceutics models (PBBM) and establish best practices in this field.
Polli is organizing an FDA/M-CERSI in-person workshop titled "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Scientific Practices to Drive Drug Product Quality: Latest Regulatory and Industry Perspectives", on Aug 29-31 2023 at Universities at Shady Grove (Rockville, MD).
The program features several AAPS members who are discussing the best scientific practices for developing PBBM models for orally administered, systemically active drug products and how these models can be leveraged for streamlining pharmaceutical drug product development, and supporting manufacturing changes and controls. Real PBBM case studies for oral drug products submitted as part of global marketing applications will be discussed by FDA, EMA, Health Canada, ANVISA, MHRA and PMDA. Visit the event webpage for the complete agenda and registration details.
Please share your experiences with PBBM to improve drug product quality in this thread.
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Amitava Mitra Ph.D., FAPPS
Senior Director
Kura Oncology
West Chester PA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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