Generics Services

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 trials, selecting the best sites in the best geographic regions for fast, rapid conduct coupled with high quality data in accordance with existing guidances.

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.

Transdermal testing

One of the key requirements for transdermal generic programs is irritation and sensitization testing. With four 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.