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.