Pharmacodynamic Study of Efficacy | bioequivalence.eu

Pharmacodynamic Study of Efficacy

Equivalent therapeutic efficacy can be investigated by measurement of the bronchodilating potency and/or the bronchoprotective potency of the test and the reference product. One or other or both of these types of study may be used to satisfy the requirements of comparative efficacy.

Protection against hyperresponsiveness can be assessed through bronchoprotection studies, either direct provocation for example with methacholine, histamine, acetylcholine or indirect provocation with adenosine monophosphate (AMP) or mannitol.

It is a minimum requirement that the study has assay sensitivity. For a study to have assay sensitivity at least two non-zero levels need to be studied and one dose level needs to be shown to be superior to the other. Therefore it is recommended that unless otherwise justified more than one dose of both the test and reference products are studied.

It is essential that doses on the steep part of the dose response curve are studied.

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Professor Hans Bisgaard • Copenhagen • Denmark • Bisgaard@copsac.com