Module 9 2021

24/03/2021

Measurements in bioassays

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

same asymptotic values

curves parallel : constant displacement

response

relative potency

log dose

Example = linear log dose-response

The Organisation for Professionals in Regulatory Affairs

17

17

Measurements in bioassays

• Without functional similarity

standard

sample

response

log dose

The Organisation for Professionals in Regulatory Affairs

18

18

9