ICH M10 Bioanalytical Method Validation Guidelines


M10 Bioanalytical Method Validation

M10 EWG Bioanalytical Method Validation

This Guideline is intended to provide recommendations for the validation of bioanalytical methods for chemical and biological drug quantification and their application in the analysis of study samples. Adherence to the principles presented in this Guideline will ensure the quality and consistency of the bioanalytical data in support of the development and market approval of both chemical and biological drugs.

The objective of the validation of a bioanalytical method is to demonstrate that it is suitable for its intended purpose. Changes from the recommendations in this Guideline may be acceptable if appropriate scientific justification is provided. Applicants are encouraged to consult the regulatory authority(ies) regarding significant changes in method validation approaches when an alternate approach is proposed or taken.

Guidelines (Click the links below for complete guidelines)

Endorsed Documents (Click the links below for complete guidelines)

WG Presentations / Trainings (Click the links below for complete guidelines)

*These Guidelines Belongs to ICH website.

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