Module 9 2024

03/09/2024

Bioassay Validation

• ICH Q2 R2 “Validation objective of an analytical procedure (AP) is to demonstrate the AP is suitable for its intended purpose” • It is a formal exercise, agreed Protocol sets out how the assay will be assessed • Pre-defined acceptance criteria defined from development data

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Bioassay Validation

Accuracy

+

Precision

Repeatability

+ intra-assay precision

Intermediate Precision + inter-assay precision

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 (ICH Q14).

The Organisation for Professionals in Regulatory Affairs

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20