The path to approval for generic topical products can be challenging. bioskin® can help you to optimally plan and implement a development strategy:
Vasoconstrictor assays according to FDA guidance
Bioequivalence of topical corticosteroids in Europe and the USA is assessed using the vasoconstrictor or human skin blanching assay as outlined in the FDA guidance. bioskin® offers a competitive package for conduct of these studies together with international experts in this field. Our exceptional team for these studies ensures that we deliver reliable, top quality results meeting agency reporting standards.
Therapeutic equivalence studies
Comparative clinical trials for therapeutic equivalence with a reference listed drug are usually required for generic approvals for drug classes other than corticosteroids. bioskin® is able to optimally plan and manage these large trials, selecting the best sites in the best geographic regions for fast, rapid conduct coupled with high quality data in accordance with existing guidances.
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.
One of the key requirements for transdermal generic programs is irritation and sensitization testing. With three dermatologists on staff with training and experience in reading these reactions, combined with our pharmaceutical know-how, 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.