ACoP 2024 Workshop 2 on PBBM - Formulation development and virtual Bioequivalence

November 15th, Arizona, USA

Model-informed drug development is extensively used in decision-making during drug development. Physiologically based biopharmaceutics modeling (PBBM) is increasingly explored to inform oral drug product development, manufacturing changes, and controls. It enables mechanistic modeling of the relationship between drug substance and formulation properties, absorption and disposition in patients or populations. There are few open-source, regulator-approved software for PBBM.

 

This workshop aims to present the principles/applications of PBBM with hands-on examples using the open-source Open Systems Pharmacology (OSP) Suite (PK-Sim®, MoBi®). The learners will:

  1. Delve into the world of mechanistic oral absorption modeling with PK-Sim®, unlocking a deeper understanding of absorption mechanisms.
  2. Learn how experts are using the OSP suite to forecast dissolution behavior and optimize drug formulations.
  3. Learn about the in vitro-in vivo correlation (IVIVC) concept and its significance in pharmaceutical development and regulatory applications, from streamlining formulation optimization to expediting regulatory approval processes.
  4. Explore ways to establish the IVIVC through the OSP Suite.
  5. Learn about virtual bioequivalence (VBE) and dissolution safe space and how these strategies are reshaping traditional approaches in the drug development space.
  6. Immerse yourself in interactive exercises, gaining experience in VBE analyses with the OSP suite, empowering you to navigate the complexities of pharmaceutical research.

While the workshop does not require prior experience with PK-Sim® and MoBi®, many topics will interest even advanced users.

Workshop Instructors:

  • Dr. Mariana Guimarães (Scientist)
  • Dr. Jean-Baptiste Jérémy Perrier (Senior Scientist)
  • Dr. Marco Siccardi (Principal Scientist)

Date: Friday, 15th November 2024

Time: 09:00 – 17:00

Location: It will be the conference hotel. More details will be provided closer to the date.

Fee: 750 USD (+tax) for the ACoP members, 950 USD (+tax) for non-members, and 450 USD (+tax) for students. The fee includes coffee breaks and lunch for both days.

Registration: Go to the ACoP registration portal.

For any further support, do not hesitate to contact us via email.

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