Modernization and Strengthening of Bioequivalence Guidelines in Japan
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LEADING ARTICLE
Modernization and Strengthening of Bioequivalence Guidelines in Japan Ryosuke Kuribayashi1 · Toru Yamaguchi1 · Kazunori Takagi2 Accepted: 5 November 2020 © Springer Nature Switzerland AG 2020
Abstract Until now, human bioequivalence (BE) studies were conducted based on the revised ‘Guideline for Bioequivalence Studies of Generic Products’ issued in 2012 by the Ministry of Health, Labour and Welfare (MHLW) in Japan. However, revisions of BE guidelines were required to account for the globalization of pharmaceutical development, new technology, and scientific rationales over the last 8 years. Therefore, the MHLW published the revised ‘Guideline for Bioequivalence Studies of Generic Products’ in 2020. In this article, we introduce the main revised contents, such as the addition of a fed-state BE study, reconsideration of the pilot study and add-on study, acceptance of foreign subjects in a BE study, and clarification of the requirement of a reference product. Furthermore, we compare the BE evaluations of generic oral solid dosage forms with those of the Pharmaceuticals and Medical Devices Agency (PMDA), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Key Points This article summarizes the main revised contents of the 2020 ‘Guideline for Bioequivalence Studies of Generic Products’, such as the addition of a fed-state bioequivalence (BE) study, reconsideration of the pilot study and add-on study, acceptance of foreign subjects in a BE study, and clarification of the requirement of a reference product. These revisions have modernized and strengthened BE evaluation for the regulations of generic drugs in Japan. This article compares the revised BE evaluations of generic oral solid dosage forms with those of the Pharmaceuticals and Medical Devices Agency (PMDA), the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA).
* Ryosuke Kuribayashi kuribayashi‑[email protected] 1
Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3‑3‑2, Kasumigaseki, Chiyoda‑ku, Tokyo 100‑0013, Japan
Office of Manufacturing Quality for Drugs, Pharmaceuticals and Medical Devices Agency, 3‑3‑2, Kasumigaseki, Chiyoda‑ku, Tokyo 100‑0013, Japan
2
1 Introduction Until now, the revised ‘Guideline for Bioequivalence Studies of Generic Products’ issued in 2012 by the Ministry of Health, Labour and Welfare (MHLW) in Japan was the reference used to conduct human bioequivalence (BE) studies [1–7]. BE studies are performed to infer the efficacy and safety of generic drug products compared with innovative drug products. Most BE studies of oral solid dosage forms are evaluated using the index of bioavailability (BA) of the area under the drug plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax). The Pharmaceuticals and Medical Devices Agency (PMDA) generally recommends selecting the highest strength possible if the innovative drug products show linear pharmacokinetics (PK). If the innovative drug products exhibit nonlinear
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