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Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan

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Abstract

The Japanese Ministry of Health, Labour and Welfare issued the basic principles for bioequivalence evaluations of generic dry powder inhaler (DPI) drug products in 2016. This document presents the recommendations of the methodology for the effective development of generic DPI drug products. Based on this document, the Pharmaceuticals and Medical Devices Agency (PMDA) advises the efficient development in the consultation meeting with generic companies. The PMDA generally requires the data of in vitro tests, pharmacokinetics studies, and clinical endpoint studies for generic development. In vitro tests play a critical role in the development of the generic versions because these tests are used to predict the efficacy and safety of other populations on whom clinical endpoint studies have not been conducted. We are aware that some points need further discussion, such as the recommendations for at least four groups of stages (group 1: the induction port and pre-separator, group 2: greater than 5 μm, group 3: ranging from 3 to 5 μm, group 4: ranging from 0.8 to 3 μm) for in vitro tests of the generic DPI products. This article shows the current understanding and recommendations with respect to in vitro tests, particularly for at least four groups of stages.

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Authors and Affiliations

  1. Office of Generic Drugs, Pharmaceuticals and Medical Devices Agency, 3-3-2, Kasumigaseki, Chiyoda-ku, Tokyo, 100-0013, Japan

    Ryosuke Kuribayashi, Aya Myoenzono, Kazunori Takagi & Mitsue Hirota

Authors
  1. Ryosuke Kuribayashi
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  2. Aya Myoenzono
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  3. Kazunori Takagi
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  4. Mitsue Hirota
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Correspondence to Ryosuke Kuribayashi.

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No external funding was used in the preparation of this manuscript.

Conflict of interest

Ryosuke Kuribayashi, Aya Myoenzono, Kazunori Takagi, and Mitsue Hirota declare that they have no conflict of interest that might be relevant to the contents of this article.

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The views expressed in this article are those of the authors and do not necessarily reflect the official views of the Pharmaceuticals and Medical Devices Agency.

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Kuribayashi, R., Myoenzono, A., Takagi, K. et al. Current Understanding of the Equivalence Evaluations for In Vitro Tests on Generic Dry Powder Inhaler Drug Products in Japan. Eur J Drug Metab Pharmacokinet 44, 743–745 (2019). https://doi.org/10.1007/s13318-019-00561-z

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  • DOI: https://doi.org/10.1007/s13318-019-00561-z

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