Fumiko Tamura
Fumiko Tamura is associate manager, GSK, CMC Regulatory Affairs, Tokyo, Japan
Articles
Risk-Based Intermediate Precision Studies for Analytical Procedure Validation
September 15th 2019Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
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