Physiologically-Based Pharmacokinetics (PBPK) Modeling and Simulation: A Transformative Tool for Early-Stage Clinical Development

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There is a wide range of pre-IND activities that depend on a reasonable prediction of the human pharmacokinetics of your development asset. Candidate selection, projection of investigational medicinal product (IMP) needs, early cost-of-goods assessment, and dosage form strengths to be manufactured are just a few of the activities that depend on an early and accurate prediction of the human pharmacokinetics of your asset. Physiologically-Based Pharmacokinetics (PBPK) modeling and simulation is a way to get these early estimates of human exposure for your compound.

By integrating physico-chemical data (solubility, pKa), in vivo estimates of plasma protein binding and permeability, as well as non-clinical pharmacokinetics in one or more species, excellent predictions of human exposure may be developed for your asset, which may allow specific enabling activities such as IMP manufacturing campaigns, dosage form design and cost-of-goods assessment to be made.  Pre-candidate selection, predictions of the human PK of one or more development candidates may result in a more rational selection of a development candidate, with the best chance for success. Although traditionally used for small molecules, Cytel has also successfully used this technique for siRNA products and biologics.

Key Topics

• A brief introduction to the basics of PBPK modeling and simulation
• A special focus on how it can be used to guide, de-risk, and expediate drug development

Speakers

• Michael Fossler, Vice President, Quantitative Clinical Pharmacology
• David Dahlgren, Senior Consultant, Clinical Pharmacology