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

Authors :
Akihiro Hisaka
Reiko Sato
Yoshiyuki Ohno
Akihiro Ishiguro
Kazuya Maeda
Naomi Nagai
Kiyomi Ito
Source :
Drug Metabolism and Pharmacokinetics. 41:100414
Publication Year :
2021
Publisher :
Elsevier BV, 2021.

Abstract

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.

Details

ISSN :
13474367
Volume :
41
Database :
OpenAIRE
Journal :
Drug Metabolism and Pharmacokinetics
Accession number :
edsair.doi.dedup.....82ce1e1a3c01a086860e8f1e04f6036e