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Analytical method validation for biomarkers as a drug development tool: points to consider

Yoshiaki Ohtsu1, Seiji Tanaka2, Harue Igarashi3

  • 1Kyowa Kirin Co., Ltd. 1188 Shimotogari, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8731, Japan.

Bioanalysis
|September 14, 2021
PubMed

Keywords:
Japanassay validationbiomarkerregulatory submissionstudy sample analysiswhite paper

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