FDA-Project: Bioequivalence of drugs in the skin
JOANNEUM RESEARCH established a method to determine the bioequivalence of drugs in the skin – within a project granted by the US Food and Drug Administration (FDA).
Generic drugs are an attractive alternative to reference listed drugs, because they have the same treatment effect but are generally available at considerably lower costs. To be approved, a generic drug must show the same therapeutic effect as the reference listed drug (bioequivalence). However, methods that can prove this bioequivalence for drugs in the skin are missing, which explains the limited number of generic drugs available for skin diseases.
JOANNEUM RESEARCH established a new method to determine the bioequivalence, Open Flow Microperfusion (OFM). With OFM, tissue fluid is collected from the skin and subsequently analyzed. That way, processes can be observed directly in the skin.
The successful application of OFM for assessing bioequivalence and non-bioequivalence of hydrophilic, topically applied creams was demonstrated within this project for the first time and various questions, such as:
- Did the drug enter the skin?
- How much of the drug entered the skin?
- How long did the drug stay within the skin?
could be answered.
The determination of bioequivalence of generic drugs in the skin and the answers to these questions by using OFM helps to accelerate the further development of generic medications in the skin.
A follow-up project with the US FDA which aims to promote the development of more effective methods for determination of bioequivalence of topical medications in the skin, has been applied for.