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

Drug Development Drug Interactions Pharmaceutical Preparations
Clinical pharmacology Decision tree Drug development Drug interaction Index drug Labeling P450 Regulatory guideline Transporter Typical drug

Journal

Drug metabolism and pharmacokinetics
ISSN: 1880-0920
Titre abrégé: Drug Metab Pharmacokinet
Pays: England
ID NLM: 101164773

Informations de publication

Date de publication:
Dec 2021
Historique:
received: 15 03 2021
revised: 24 06 2021
accepted: 27 06 2021
pubmed: 20 10 2021
medline: 14 1 2022
entrez: 19 10 2021
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1016/j.dmpk.2021.100414 PMID: 34666290
pubmed: 34666290
pii: S1347-4367(21)00035-5
doi: 10.1016/j.dmpk.2021.100414
pii:
doi:

Substances chimiques

Pharmaceutical Preparations 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

100414

Informations de copyright

Copyright © 2021 The Japanese Society for the Study of Xenobiotics. Published by Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare no conflict of interest. The views presented in this article are those of authors and do not necessarily reflect the official position of the Pharmaceuticals and Medical Devices Agency.

Auteurs

Kazuya Maeda (K)

Graduate School of Pharmaceutical Sciences, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan; Kitasato University School of Pharmacy, 5-9-1 Shirokane, Minato-ku, Tokyo, 108-8641, Japan. Electronic address: maedak@pharm.kitasato-u.ac.jp.

Akihiro Hisaka (A)

Graduate School of Pharmaceutical Sciences, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, 260-8675, Japan. Electronic address: hisaka@chiba-u.jp.

Kiyomi Ito (K)

Research Institute of Pharmaceutical Sciences, Musashino University, 1-1-20 Shin-machi, Nishitokyo-shi, Tokyo, 202-8585, Japan. Electronic address: k-ito@musashino-u.ac.jp.

Yoshiyuki Ohno (Y)

Department of Pharmacy, Faculty of Medicine, The University of Tokyo Hospital, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan. Electronic address: yohno-tky@umin.ac.jp.

Akihiro Ishiguro (A)

Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg. 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. Electronic address: ishiguro-akihiro@pmda.go.jp.

Reiko Sato (R)

Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Bldg. 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. Electronic address: sato-reiko@pmda.go.jp.

Naomi Nagai (N)

Research Institute of Pharmaceutical Sciences, Musashino University, 1-1-20 Shin-machi, Nishitokyo-shi, Tokyo, 202-8585, Japan. Electronic address: n_nagai@musashino-u.ac.jp.

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Classifications MeSH

questionsmedicales.fr › Techniques d'investigation › Développement de médicament › Classification of drugs for evaluating drug...
questionsmedicales.fr › Phénomènes physiologiques › Phénomènes pharmacologiques et toxicologiques › Phénomènes pharmacologiques › Interactions médicamenteuses › Classification of drugs for evaluating drug...
questionsmedicales.fr › Préparations pharmaceutiques › Classification of drugs for evaluating drug...