Classification of drugs for evaluating drug interaction in drug development and clinical management

During new drug development, clinical drug interaction studies are carried out in accordance with the mechanism of potential drug interactions evaluated by in vitro studies. The obtained information should be provided efficiently to medical experts through package inserts and various information materials after the drug's launch. A recently updated Japanese guideline presents general procedures that are considered scientifically valid at the present moment. In this review, we aim to highlight the viewpoints of the Japanese guideline and enumerate drugs that were involved or are anticipated to be involved in evident pharmacokinetic drug interactions and classify them by their clearance pathway and potential intensity based on systematic reviews of the literature. The classification would be informative for designing clinical studies during the development stage, and the appropriate management of drug interactions in clinical practice. (C) 2021 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd.

Automated summary

This review highlights the importance of clinical drug interaction studies during new drug development and introduces the general procedures proposed in a recently updated Japanese guideline. Drugs are classified based on their clearance pathway and potential intensity according to systematic reviews of the literature, which is useful for managing drug interactions in clinical practice.