Module 9 2021

24/03/2021

Bioassay Validation

• ICH Q2(R1): Validation of analytical procedures: Text and Methology

• U.S. Pharmacopeia (USP) 1033: Biological Assay Validation

• FDA Analytical Procedures and Methods Validations for Drugs and Biologics

The Organisation for Professionals in Regulatory Affairs

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Bioassay Validation

Accuracy

+

Precision

Repeatability + intra-assay Intermediate Precision + inter-assay Specificity + formulation Linearity + Range + Robustness **

• **robustness is not listed in the table but should be considered at an appropriate stage in the development of the analytical procedure.

The Organisation for Professionals in Regulatory Affairs

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