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Workshop: Leveraging in vitro data within PBPK

Workshop: Leveraging in vitro data within PBPK

This workshop offers hands-on training in integrating in vitro data into Physiologically-Based Pharmacokinetic (PBPK) modeling for IVIVE and virtual bioequivalence trials.

Overview

This workshop delivers a comprehensive approach to leveraging in vitro data in PBPK modeling for drug development. Participants will learn best practices for integrating preclinical data, understand the IVIVE process, and explore how in vitro dissolution data can inform virtual bioequivalence trials. Hands-on exercises will reinforce learning through real-world case studies.

Workshop goals

Equip participants with a strong foundation in PBPK principles and applications for early drug development, enabling them to apply these techniques effectively in research and regulatory decision-making.

Workshop learning objectives

By the end of this workshop, participants will:

Understand the role of PBPK in drug development, particularly for first-in-human PK predictions.
Learn to integrate preclinical in vitro and in vivo data for IVIVE and FIH predictions.
Use in vitro dissolution data for virtual bioequivalence trials.

Key topics covered

PBPK in drug development
First-in-human (FIH) PK predictions
In vitro-in vivo extrapolation (IVIVE)
Preclinical data integration (in vitro, in vivo)
Virtual bioequivalence trials using dissolution data

Target audience

This workshop is ideal for professionals interested in PBPK modeling, including scientists involved in drug development, biopharmaceutics experts, and researchers focused on preclinical-to-clinical extrapolation.

Workshop requirements

Participants must bring a laptop with the required software installed. Basic knowledge of pharmacokinetics and modeling is recommended but not required.

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Pharmetheus AB
Kungsängstull 4  
753 19 Uppsala, Sweden

Visiting address:  
Dragarbrunnsgatan 77, 5th floor

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Pharmetheus is a consultancy firm helping clients reduce uncertainty in technical and regulatory processes, increasing confidence in the development of new medicines that can improve patients’ lives.

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