ABSTRACT
In the course of developing a topical dermatological product, the benefit and/or
regulatory recommendation for the establishment of product bioequivalence
presents at a number of key stages. Bioequivalence documentation is required
to support New Drug Application (NDA) and abbreviated New Drug Application
(ANDA) submissions (1). The data may be used to support changes between
formulations used in clinical trials, to link formulations used in trials and stability
studies (if different), and to support progression from clinical trial formulations to
the proposed commercial product (2). All topical drug products intended for
marketing under an abbreviated application are required to generate evidence of
in vivo bioequivalence (3). In addition, if the inactive ingredients in an ANDA are
not the same as the reference listed drug, the applicant should demonstrate to the
agency that the change(s) do not affect the safety and/or efficacy of the proposed
drug product. The Food and Drug Administration (FDA) guideline suggests that a
comparative BA study could satisfy this recommendation.