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This article entitled “Conversations with… Will Ganley, on OINDPs: Physiologically-Based Pharmacokinetic (PBPK) models for OINDPs” provides an in-depth discussion on the use of PBPK models in the development of Orally Inhaled and Nasal Drug Products (OINDPs).
The article emphasizes the importance of PBPK models (Physiologically based pharmacokinetic modeling ) in understanding drug transport to, and activity at, the site of action for these drugs. It highlights the challenges of traditional tools, such as imaging techniques and animal studies, in providing relevant and accurate data. Physiologically-Based Pharmacokinetic models, on the other hand, offer a more robust and reliable approach to understanding drug delivery and activity. The article also discusses the factors driving the adoption of PBPK models. Accessibility, regulatory support, and potential rewards such as faster time to market are among the key drivers. The article further explains how PBPK models are developed and validated, and how they can be transferred across dosage forms and species. The challenges and limitations of Physiologically-Based Pharmacokinetic models are also addressed. The complexity of biological structures, the difficulty of measuring local tissue concentrations, and the balance between model complexity and available data are among the key challenges. Despite these, the potential of PBPK models to significantly impact product development is emphasized. The article concludes with advice for those looking to implement or use PBPK modeling to support their OINDP development. It encourages setting clear goals, exploring available software solutions, and seeking expert help if needed.
