By Lisa Craig, BS; Chris Papagiannis, BS; and Duane Poage, MS
Development of dermal compounds for the pharmaceutical market can require differing approaches, depending on whether the compound is a new chemical entity (NCE) or a formulation of a previously marketed drug. In today’s research environment, developing a dermal NCE generally follows the same path as other small molecule NCEs administered orally or systemically, except that the dermal route is used in a non-rodent model. Rodent models can be used for systemic evaluations (e.g., subcutaneous, oral) to provide potential systemic toxicity data. Rodent models can employ a systemic route (e.g., subcutaneous, oral) to provide potential systemic toxicity data. This article will touch on a few points regarding dermal studies in the non-rodent model.
A dermal toxicology package will differ depending on if the study is for a new drug, an additional indication, or a new formulation for a previously approved drug. If it’s for the latter, the 505(b)(2) pathway can be used, in which systemic data from previous studies provides support, precluding the need for a generation of entirely new study data for the regulatory agency (FDA, etc.). In this case, it is generally necessary to perform the toxicology study via the dermal route in the non-rodent species (most often the minipig).