論文

査読有り
2013年

Bringing phase I trials in healthy subjects to Japan: Current practices and future directions

International Journal of Pharmacy and Pharmaceutical Sciences
  • Akira Shishido
  • ,
  • Sachiko Masuda
  • ,
  • Hiromichi Kimura

5
SUPPL.4
開始ページ
51
終了ページ
55
記述言語
掲載種別
研究論文(学術雑誌)

Objective: Recently, the number of phase I trials being conducted in different regions has been changing. From the pharmaceutical industry's point of view, it is important to focus on selection of the appropriate study country. This study was conducted to investigate Japan's capabilities in conducting phase I studies in healthy subjects. Methods: A structured questionnaire survey was performed to identify unique features of phase I sites in Japan. The questionnaires were administered to 15 phase I sites in Japan, sites at which over 90% of all phase I studies of new molecular entities in healthy subjects in Japan are conducted each year. Results: 165 phase I trials of new molecular entities in healthy subjects are conducted per year. This survey revealed three features of phase I sites in Japan: (1) subjects are recruited quickly, (2) sites can perform studies with both New Molecular Entities and Generic Entities, (3) the majority of these phase I sites have adopted the requirements outlined in the Medicines and Healthcare Products Regulatory Agency accreditation scheme that is practiced in the UK. Conclusions: Our survey suggests that Japan currently has highly qualified phase I sites, in terms of quality, speed, cost and experience. However, improvements must still be made in order to gain global recognition and to promote Japan's capabilities in early stage clinical trials.

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Scopus
https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=84888354301&origin=inward
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ID情報
  • eISSN : 0975-1491
  • SCOPUS ID : 84888354301

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