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Current Regulation for Bioequivalence Evaluations of Generic Ophthalmic Dosage Forms in Japan.
Myoenzono, Aya; Kuribayashi, Ryosuke; Yamaguchi, Toru; Ogawa, Takumi; Takagi, Kazunori.
Afiliación
  • Myoenzono A; Office of International Programs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan. myoenzono-aya@pmda.go.jp.
  • Kuribayashi R; Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
  • Yamaguchi T; Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
  • Ogawa T; Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
  • Takagi K; Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan.
Eur J Drug Metab Pharmacokinet ; 45(6): 697-702, 2020 Dec.
Article en En | MEDLINE | ID: mdl-32930951
In Japan, the revised version of bioequivalence (BE) evaluations for generic drug products was made available in 2012; however, the scope of this guideline is mainly oral solid dosage forms. Other dosage forms have to be discussed regarding how to evaluate BE by applicants and regulators during consultation meetings or the review process. Recently, there has been an increase in developing generic drug products in various dosage forms in Japan. Therefore, the Pharmaceuticals and Medical Devices Agency (PMDA) must strengthen their efforts to establish methodologies for BE evaluations for various dosage forms, including those of ophthalmic drugs. In 2016, the Japanese Ministry of Health, Labour and Welfare (MHLW) issued "The basic principles of bioequivalence evaluations of generic ophthalmic aqueous solutions." This document presents recommendations for clinical endpoint BE studies or biowaiver options to evaluate the BE of generic ophthalmic aqueous solutions. However, this document has brought other issues to the forefront, such as the lack of feasibility of human BE studies for certain indications. Therefore, the PMDA, Japan Ophthalmic Pharmaceutical Manufacturer's Association, and BE experts discussed these issues for 2 years, which led to an update by MHLW in 2018 entitled "The basic principles of bioequivalence evaluations of generic ophthalmic dosage forms." This document describes methodologies for evaluating the BE of ophthalmic dosage forms including suspensions. This article introduces recently approved generic products of ophthalmic dosage forms in Japan, the basic principle of which was issued in 2018, and compares the BE evaluations between the PMDA and U.S. Food and Drug Administration.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Soluciones Oftálmicas / Equivalencia Terapéutica / Medicamentos Genéricos / Legislación de Medicamentos Tipo de estudio: Guideline Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Eur J Drug Metab Pharmacokinet Año: 2020 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Francia
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Soluciones Oftálmicas / Equivalencia Terapéutica / Medicamentos Genéricos / Legislación de Medicamentos Tipo de estudio: Guideline Límite: Humans País/Región como asunto: Asia Idioma: En Revista: Eur J Drug Metab Pharmacokinet Año: 2020 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Francia