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

• Published in: Drug metabolism and pharmacokinetics Vol. 41; p. 100414
• Main Authors: Maeda, Kazuya, Hisaka, Akihiro, Ito, Kiyomi, Ohno, Yoshiyuki, Ishiguro, Akihiro, Sato, Reiko, Nagai, Naomi
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.12.2021
• Subjects: Clinical pharmacology; Decision tree; Drug Development; Drug interaction; Drug Interactions; Index drug; Labeling; P450; Pharmaceutical Preparations; Regulatory guideline; Transporter; Typical drug; Regulatory guideline; Typical drug; Index drug; Clinical pharmacology; Drug interaction; P450; Drug development; Labeling; Decision tree; Transporter
• ISSN: 1347-4367; 1880-0920; 1880-0920
• DOI: 10.1016/j.dmpk.2021.100414

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.