Positive implications of PBPK platform qualification for predicting drug-drug interactions: Taking on cracks only to...

In this mini-review, the readers are provided with series of key references which highlight the latest trends in the space of physiologically-based pharmacokinetics (PBPK) concerning assessment and management of drug-drug interactions (DDI). Over the last two decades such applications have moved from an academic nicety to industrial necessity, and then regulatory requirement. However, the regulatory uptake has not been uniform and it has not taken the same path. These have been a reflection of the set up in various regulatory agencies and their breadth and depth of work-force, centralized or de-centralized nature of geographical distribution of assessors, existence or lack of internal research groups to examine multi-layer large scale models and many other factors. However, despite these operational differences, recent qualification opinion by EMA on platforms used for PBPK evaluation in the space of DDI is a significant step that heralds a general worldwide consensus for harmonization in use of these new technologies as a follow up to efforts within International Harmonization Committee in the space via publication of their M12 Guidance. Readers will get to know the journey that has taken us to this point and some forthcoming directions on expansion of applications.