Spring Intro 2023

16/02/2023

Concept of Bioequivalence

Demonstration of bioequivalence to a reference product enables bridging to their preclinical and clinical data.

1. Drug is administered 2. Drug enters systemic circulation 3. Drug reaches site of action at required concentrations 4. Drug exerts a pharmacodynamic effect 5. Pharmacodynamic effect achieves clinical outcome

If one can demonstrate that the drug reaches the site of action at the same concentration as for a reference product then one can conclude a comparable pharmacodynamic effect and hence clinical outcome

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Establishing Bioequivalence Concept revolves around comparing plasma concentration profiles for test and reference product after administration under controlled conditions:

Two key parameters that enable comparisons of profiles:

Cmax

Cmax: Maximum plasma concentrations achieved

Test Reference

AUC: Area under the curve

AUC

Some other parameters may also measured (e.g. Tmax)

Plasma concentration (ng/ml)

Time (hours)

The Organisation for Professionals in Regulatory Affairs

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