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Bioequivalence Requirements in Various Global Jurisdictions

Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 28))

Abstract

Generic drug products comprise a relatively small proportion of the total pharmaceutical market in Japan. Generic drug products in 2007 accounted for as little as 18.7% of the market by volume and around 6.6% by value according to the survey of the Ministry of Health, Labour, and Welfare (MHLW) [1]. These figures pale in comparison with countries such as the United States, Germany, and the United Kingdom where generic drug product penetration levels are far more than half of the total pharmaceutical products volume.

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Author information

Authors and Affiliations

  1. Sawai Pharmaceutical Co., Ltd., Osaka, Japan

    Juichi Riku

  2. SHIONOGI & CO., LTD., Osaka, Japan

    Noriyuki Muranushi

Authors
  1. Juichi Riku
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  2. Noriyuki Muranushi
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Corresponding author

Correspondence to Juichi Riku .

Editor information

Editors and Affiliations

  1. Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa

    Isadore Kanfer

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© 2017 American Association of Pharmaceutical Scientists

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Riku, J., Muranushi, N. (2017). Japan. In: Kanfer, I. (eds) Bioequivalence Requirements in Various Global Jurisdictions. AAPS Advances in the Pharmaceutical Sciences Series, vol 28. Springer, Cham. https://doi.org/10.1007/978-3-319-68078-1_6

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