Biomarker assay validation for clinical trials: a questionnaire survey to pharmaceutical companies in Japan

Bioanalysis. 2019 Jan;11(2):55-60. doi: 10.4155/bio-2018-0257. Epub 2018 Nov 26.

Authors

Affiliations

¹ Astellas Pharma Inc., Tsukuba, Ibaraki, Japan.
² Otsuka Pharmaceutical Co., Ltd, Osaka, Japan.
³ Astellas Pharma Inc., Tokyo, Japan.
⁴ Takeda Pharmaceutical Company Limited, Fujisawa, Kanagawa, Japan.
⁵ Taiho Pharmaceutical Co., Ltd, Tsukuba, Ibaraki, Japan.
⁶ National Institute of Health Sciences, Kawasaki, Kanagawa, Japan.
⁷ Mitsubishi Tanabe Pharma Corporation, Yokohama, Kanagawa, Japan.
⁸ Shin Nippon Biomedical Laboratories, Ltd, Kainan, Wakayama, Japan.
⁹ Aska Pharmaceutical Co., Ltd, Kawasaki, Kanagawa, Japan.

PMID: 30475072
DOI: 10.4155/bio-2018-0257

No abstract available

Keywords: Japan; assay validation; biomarker; clinical trials; standard operating procedure.

MeSH terms

Biological Assay* / statistics & numerical data
Biomarkers / analysis*
Clinical Trials as Topic / methods*
Clinical Trials as Topic / statistics & numerical data
Drug Discovery / methods*
Drug Discovery / statistics & numerical data
Drug Industry* / statistics & numerical data
Japan
Pharmaceutical Preparations
Surveys and Questionnaires

Substances

Biomarkers
Pharmaceutical Preparations