Request Copyright Permission

De-risking Inhalation Product Development Using Predictive Models

Bäckman P, Olsson B.

RDD Asia 2018. Volume , 2018: 83-92.

Abstract:

The complexity of inhaled drug products and their local site of action merits careful consideration as to the nature of key product attributes regulating clinical and pharmaceutical performance, how to assess them, and how to link these measures to clinical performance.

This paper discusses the nature of these performance attributes and our ability to experimentally assess them using predictive experimental models. We also explore the potential of computer-based physiology-based pharmacokinetic (PBPK) models to increase our understanding of the link between in vitro performance measures and clinical performance, thus de-risking development of inhaled medicines.