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Proposal for risk-based scientific approach on full and partial validation for general changes in bioanalytical

Ayumi Mochizuki1, Katsunori Ieki2, Hiroshi Kamimori3

  • 1Office of Clinical Pharmacology, Department of Clinical Management, Headquarters of Clinical Development, Otsuka Pharmaceutical Co., Ltd., 3-2-27 Otedori, Chuo-ku, Osaka 540-0021, Japan.

Bioanalysis
|April 11, 2018
PubMed

Keywords:
LC−MS/MS analysisbioanalytical method validationpartial validationrisk-based approachsmall molecules

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