ICH Q2 (R1) Validation of analytical procedures: text and methodology

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Current effective guideline

Adopted guideline

Reference numberCPMP/ICH/381/95

01/11/1994 (part I)

01/12/1996 (part II)

Effective from

01/06/1995 (part I)

01/06/1997 (part II)

KeywordsValidation, analytical procedures, accuracy, precision, specificity, detection limit, quantitation limit, linearity, range
DescriptionThis document discusses the characteristics for consideration during the validation of the analytical procedures included as part of registration applications submitted within the EC, Japan and USA. It serves as a collection of terms, and their definitions, and is not intended to provide direction on how to accomplish validation.

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