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This paper discusses an application of statistics in analytical method validation. The objective of this paper is to provide an overview of regulatory expectations related to statistical analysis and the review of common statistical techniques used to analyze analytical method validation data with specific examples. The examples provided cover the minimum expectations of regulators.
The following key points are presented:
- Regulatory guidelines regarding statistical data analysis in analytical method validation.
- Statistics to analyze data for analytical method validation such as mean, standard deviation, confidence intervals, and linear regression.
- Data analysis using statistical packages such as Minitab and Excel are discussed.