Module 9 2024

03/09/2024

Measurements in Bioassays

• Functional similarity of reference and sample is a fundamental condition for determination of a valid relative potency

D.

same asymptotic values (lower & upper A&D)

curves parallel : constant displacement % relative potency = shift in sample on x axis

C.

Signal

response

A.

log dose

Example = linear log dose-response

• Data can be log transformed to attain normality - USP 1033 “ Relative potency measurements are typically log normally distributed”

The Organisation for Professionals in Regulatory Affairs

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Measurements in Bioassays

Reference Expectations • At the time of submission, the product should have been compared with an appropriate reference standard… (ICH Q6B)

• … it should be compared with its natural counterpart… (ICH Q6B)

• More likely that early batches differ… so may need to replace initial in -house reference with representative production/clinical material (ICH Q5E)

The Organisation for Professionals in Regulatory Affairs

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