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. 2021 Dec;10(12):1410-1418.
doi: 10.1002/cpdd.1044. Epub 2021 Nov 26.

Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?

Masaru Hirano  1 , Masanori Yamada  2 , Toshiaki Tanaka  3 , Toshiko Koue  3 , Tomohisa Saito  4 , Mitsuo Higashimori  5 , Hisao Ochiai  6 , Junichi Yamamoto  7   8 , Saori Yaguchi  9 , Sachiko Mita  10 , Katsutoshi Hara  2 ; EFPIA Japan Technical Committee PK/PD Task Force
Affiliations

Surveys/Research Exploring Japanese Phase I Studies in Global Drug Development: Are They Necessary Prior to Joining Global Clinical Trials?

Masaru Hirano et al. Clin Pharmacol Drug Dev. 2021 Dec.
No abstract available

Keywords: Japanese; dosage regimen; drug dose; ethnic sensitivity/difference; phase I study; regulatory science.

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Conflict of interest statement

M.H. is a current employee of Novartis Pharma K.K. K.H. and M.Y. are current employees of GlaxoSmithKline K.K. T.T. and T. K. are current employees of Bayer Yakuhin Ltd. T.S. is a current employee of Chugai Pharmaceutical Co., Ltd. M.H. is a current employee of AstraZeneca K.K. H.O. is a current employee of Merck Biopharma Co., Ltd. J.Y. was an employee of UCB Japan Co., Ltd. at the time the study was conducted. S.Y. is a current employee of Novo Nordisk Pharm Ltd. S.M. is a current employee of Janssen Pharmaceutical K.K. Writing of this paper did not require any separate funding, and the authors declared no conflict of interest above their employment with the pharmaceutical companies indicated.

Figures

Figure 1
Figure 1
Information about current status of Japanese phase I studies in Japan (N = 9; survey 1). “Conducted mainly in Japan” means a J‐PhI study is usually conducted in Japan, but sometimes Japanese subjects participate in an FIH study conducted outside Japan or a separate J‐PhI study is conducted outside Japan. FIH, first‐in‐human; N/A, not applicable (as 1 company did not develop any oncology drugs); PMDA, Pharmaceuticals and Medical Devices Agency.
See this image and copyright information in PMC

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