Description
1 Day IN PERSON EVENT - Simcyp Biopharmaceutics – Recent Advances and Applications
22 May 2024 – Sannomiya Training Center, Kobe, Japan
The impact and acceptance of Physiologically-Based Pharmacokinetic (PBPK) modelling continues to exhibit strong growth within the pharmaceutical industry, and PBPK approaches are increasingly being advocated by regulatory agencies to streamline drug development. The US FDA has released its draft guidance on this in Oct 2020: ‘The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls’ https://www.fda.gov/media/142500/download.
PBPK or Physiologically-Based Biopharmaceutics modelling (PBBM), whether for new drugs or generics, clinical stage or biopharmaceutics/formulation, has clearly demonstrated its value in saving time and budget, while strengthening internal decision-making. At this event we will present recent development in the biopharmaceutics module of the Simcyp Simulator and through several real-word case studies illustrate the increased adoption of Model Informed Formulation Development (MIFD) by sponsors and acceptance by regulators.
There are many applications to integrate these technologies into drug programs, specifically to support:
- Predicting the outcome of a Bioequivalence (BE) study comparing test and reference formulations
- Formulation changes in late stage clinical development
- Dissolution specification setting
- Manufacturing site change
- Waiver of BE study
- Minimize the number of “pilot” PK studies
- Provide more confidence in the outcome of a “pivotal” BE study
Objectives
Events objectives:
- To get familiar with the latest developments in the Simcyp Biopharmaceutics module
- Getting familiar with the latest regulatory acceptance of PBPK applications in biopharmaceutics area
- Real world applications of Simcyp Biopharmaceutics module
For further references please see: WP_Model-Informed-Formulation-Development_Final-5-2-23.pdf (certara.com).
Workshop attendees may be eligible for a free evaluation license of the Simcyp Biopharmaceutics Simulator.
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