Module 9 2024

03/09/2024

Measurements in Bioassays

Measurable functional relevant

biological system

Therapeutic

biological response

complex

subject to many variables

• The measured response will vary between assays

The Organisation for Professionals in Regulatory Affairs

11

11

Measurements in Bioassays

Efficacy

•

Ability of therapeutic to elicit intended response

Potency

•

Quantity of therapeutic needed to elicit the intended response

The Organisation for Professionals in Regulatory Affairs

12

12

6