Pharmaceutical statisticsValidation Studies as TopicConfidence IntervalsStatistics as Topic
Confidence Intervals for Validation of Analytical Procedures Under ICH Q2(R2).
Paul Faya, Chad N Wolfe, Adam P Rauk
Published: 202610.1002/pst.70055
Abstract
The International Conference on Harmonisation (ICH) adopted revision 2 (R2) of its Quality Guidance Q2 Validation of Analytical Procedures in 2023. The revision includes a new statement that confidence interval limits for validation performance chara…
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