Making science work

Target groups

This seminar is intended for all scientists with an interest in oral drug absorption. This includes academics and early stage researchers (graduate students), scientists from the Pharmaceutical Industry working in Research and Development (e.g. Discovery, Drug Metabolism and Pharmacokinetics, Formulation and Process Design, Analytics, Clinical Pharmacology) and in Regulatory Affairs as well as those working in related departments in Regulatory Authorities.

Objective

The primary goal of the seminar is to explore the various methodologies that are being used to determine drug permeability in the gastrointestinal tract and to identify how they are applied in the different stages of drug development (Discovery, Preclinical Development and Clinical Development).

Experts in the various methods applied to measure/estimate permeability values, ranging from in silico and in vitro predictions all the way through to studies in humans, will share their experience and expertise. During the panel sessions, the participants will have the opportunity to ask specific questions and interact directly with the experts. The intention is to not only describe the various methods but also to point out potential flaws and assumptions which can affect the results and their interpretation, and to establish best practices for each method as well as the selection of the most appropriate method in each stage of drug development. In addition, the impact of permeability estimations on PK predictions in PBPK modelling and the degree to which excipients can affect drug permeability in clinical studies will be addressed.

At the end of the seminar, the participants will know:

• about the various methods used for measuring/ estimating permeability including their advantages and limitations,
• about the latest developments in measuring permeability,
• how to select the most appropriate method for a given situation in the development of an oral drug product,
• about the challenges around reliability of permeability assessment,
• how to apply permeability values in PBPK modeling and
• to what degree excipients are likely to affect drug permeability.