title: Regulatory Considerations of Bioequivalence Studies for Oral Solid Dosage Forms in Japan.
abstract: Bioequivalence (BE) studies are used to infer the therapeutic equivalence of generic drug products to original drug products throughout the world. In BE studies, bioavailability (BA) should be compared between the original and generic drug products, with BA defined as the rate and extent of absorption of active pharmaceutical ingredients or active metabolites from a product into the systemic circulation. For most of BE studies conducted during generic drug development, BA comparisons are performed in single-dose studies. In Japan, the revised "Guideline for Bioequivalence Studies of Generic Products" was made available in 2012 by the Ministry of Health, Labour, and Welfare, and generic drug development is currently conducted based on this guideline. Similarly, the U.S. Food and Drug Administration and European Medicines Agency have published guidance and guideline on generic drug development. This article introduces the guideline on Japanese BE studies for oral solid dosage forms and the dissolution tests for the similarity and equivalence evaluation between the original and generic drug products. Additionally, we discuss some of the similarities and differences in guideline between Japan, the United States, and the European Union.
authors.affiliation: Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan. Electronic address: kuribayashi-ryosuke@pmda.go.jp.
authors.forename: Ryosuke
authors.initials: R
authors.lastname: Kuribayashi
authors.affiliation: Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, Shin-Kasumigaseki Building, 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, Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Mikami
mesh_terms: D000284:Administration, Oral; D003692:Delayed-Action Preparations; D017277:Drug Approval; D016568:Drugs, Generic / Q000008:administration & dosage / Q000493:pharmacokinetics* / Q000592:standards; D033161:Government Regulation; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D007564:Japan; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D012995:Solubility; D013810:Therapeutic Equivalency
chemical_list: D003692:Delayed-Action Preparations; D016568:Drugs, Generic
keywords: Biopharmaceutics Classification System; bioavailability; bioequivalence; dissolution; pharmacokinetics; regulatory science