Physiologically-based Pharmacokinetic Models (PBPK) for OINDPs

Physiologically-based Pharmacokinetic Models (PBPK) offer considerable potential to accelerate the development of orally inhaled and nasal drug products (OINDPs), and our ability to construct them is evolving fast.

This Q&A offers an introduction to PBPK models, examining barriers to implementation and progress to date.

The unique value of PBPK models for OINDPs is discussed and transferability, from species to species and between product types is explained. The need for and benefits of a more standardized approach and off-the-shelf software are highlighted. Going forward the expectation is that PBPK models will play an increasingly important role in both OINDP development and associated regulatory submissions. This Q&A provides a perfect introduction for those looking to learn more from pioneers in the field.