Скачать или смотреть Avoiding Statistical Pitfalls during Method Validation

The ICH guideline on Validation of Analytical Procedures (Q2R1) delineates the guidance and methodology for validation characteristics of an analytical procedure.

Like most guidelines, the terminology is vague enough to allow for several acceptable approaches and analysis. Appropriate statistical methods should be used and all relevant data collected during validation and formulae used for calculating validation characteristics should be submitted and discussed as appropriate.

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