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

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

¹ Translational Medicine Japan, Novartis Institutes for Biomedical Research, Novartis Pharma K.K., Tokyo, Japan.
² Clinical Pharmacology Asian Hub, GlaxoSmithKline K.K., Tokyo, Japan.
³ Clinical Sciences, Research & Development Japan, Bayer Yakuhin Ltd., Tokyo, Japan.
⁴ Clinical Pharmacology Department, Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.
⁵ Science & Data Analytics, R&D, AstraZeneca K.K., Osaka, Japan.
⁶ Non-Clinical, Chemistry, Manufacturing and Control Development & Translational Medicine, Research & Development Institute, Merck Biopharma Co., Ltd., Tokyo, Japan.
⁷ Clinical Pharmacology, Strategy & Planning for East Asia Region, UCB Japan Co., Ltd., Tokyo, Japan.
⁸ Current address: Clinical Pharmacology, Research & Development, Biogen Japan Ltd., Tokyo, Japan.
⁹ Clinical, Medical, Regulatory Development Division, Novo Nordisk Pharm Ltd., Tokyo, Japan.
¹⁰ Clinical Pharmacology Department, Quantitative Sciences Division, R&D, Janssen Pharmaceutical K.K., Tokyo, Japan.

No abstract available

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

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