1. Code of Federal Regulations, Title 21, Part 320, Revised as of April1, 2014.
2. Drug Price Competition and Patent Restoration Act of 1984, Public Law 98-417, 98 Stat 1585–1605, Sept. 24, 1984
3. Flynn GL. General introduction and conceptual differentiation of topical and transdermal drug delivery systems. Topical drug bioavailability, bioequivalence, and penetration,pp. 369–91, edited by Vinod P.Shah and Howard I Maibach, Plenum Press, New York, 1993.
4. Title 21 Code of Federal Regulations Part 320. Types of evidence to establish bioavailability or bioequivalence. US Department of Health and Human Service. Revised 1 April 2013
5. FDA Guidance for Industry. Statistical approaches to establishing bioequivalence. January 2001.