Early Stage Clinical

Paul A. Lehman, QPS’ Vice President and Head of Dermal and Transdermal Research Co-authors Book Chapter on Establishing the Bioequivalence (BE) of Topical Drug Products - February, 2014

Establishing the bioequivalence (BE) of topical drug products is not a simple process: in contrast to oral medications, the process for most topical products entails costly and time-consuming clinical trials. In the United States, provisions within Food and Drug Administration (FDA) regulations allow the use of other methods (i.e. surrogates for clinical trials) to establish BE. The FDA’s stated preference is for pharmacodynamics effect studies, but in vivo animal studies and in vitro studies are also potentially acceptable. Although, currently, only one surrogate test for topical products (the “skin blanching” or “vasoconstrictor assay” for glucocorticoids) is approved, FDA activity over the past twenty-five years, through sponsored scientific meetings and research, as well as in-house research and initiatives, has led to the development of several alternative test methods for topical products.

PA Lehman, SG Raney, and TJ Franz. Topical Bioequivalence: A Comprehensive Approach Using Multiple Surrogate Methods. Advances in Dermatological Sciences. KR Brain and RP Chilcott eds., RCS Publishing, Cambridge, UK, 2014, Chap. 17


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