title: Bioequivalence Evaluations of Generic Dry Powder Inhaler Drug Products: Similarities and Differences Between Japan, USA, and the European Union.
abstract: In Japan, the development of generic oral dry powder inhaler (DPI) drug products for marketing approval has recently increased. The Pharmaceuticals and Medical Devices Agency (PMDA) considers the required data for each drug product in the consultation meeting. However, guidelines for DPI drug products have been published by the US Food and Drug Administration and the European Medicines Agency. Recently, the basic principles of bioequivalence evaluations of generic DPI drug products were published in March 2016 by the Ministry of Health, Labour and Welfare. The document mainly outlines the current understanding regarding the bioequivalence evaluations of generic DPI drug products based on knowledge from PMDA consultation meetings. In this review, we compared the bioequivalence evaluations of DPI drug products among Japan, USA, and the European Union and discuss future development of generic DPI drug products in Japan.
authors.affiliation: Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. kuribayashi-ryosuke@pmda.go.jp.
authors.forename: Ryosuke
authors.identifier: 0000-0002-6778-7114
authors.initials: R
authors.lastname: Kuribayashi
authors.affiliation: Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
authors.forename: Toru
authors.initials: T
authors.lastname: Yamaguchi
authors.affiliation: Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
authors.forename: Hanaka
authors.initials: H
authors.lastname: Sako
authors.affiliation: Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
authors.forename: Tomoko
authors.initials: T
authors.lastname: Takishita
authors.affiliation: Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
authors.forename: Kazunori
authors.initials: K
authors.lastname: Takagi
mesh_terms: D017277:Drug Approval / Q000379:methods; D016568:Drugs, Generic / Q000008:administration & dosage* / Q000592:standards*; D058995:Dry Powder Inhalers / Q000592:standards*; D005062:European Union; D006801:Humans; D007564:Japan; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D016568:Drugs, Generic