Generics
Global Expertise, Personal Touch
Clinical Development – Generics
The path to approval for generic topical products can be challenging. Eurofins bioskin can help you to optimally plan and implement a development strategy:
Therapeutic equivalence studies
Comparative clinical trials for therapeutic equivalence with a reference listed drug are usually required for generic approvals. Eurofins bioskin is able to optimally plan and manage these trials, selecting the best sites in the best geographic regions for fast, rapid conduct coupled with high quality data in accordance with existing guidances.
Transdermal testing
One of the key requirements for transdermal generic programs is irritation and sensitization testing. With five dermatologists on staff with training and experience in reading these reactions, combined with our pharmaceutical know-how, Eurofins bioskin is an ideal partner for these studies. We offer complete packages for bioequivalence (PK) and irritation/sensitization testing for patches or other transdermal formulations with program management and oversight from one hand.
Formulation screening
Using our models such as the Psoriasis Plaque Test or UV-Induced Erythema we are able to screen generic formulations for a number of drug classes. This can provide confidence before committing to costly and lengthy clinical endpoint studies. This approach is well suited to topical anti-psoriatics and many anti-inflammatories, and can provide crucial information quickly using small panels.
