1. US Code of Federal Regulations Title 21, Section 320.1(e). US Government Printing Office, Washington, DC, 2006.
2. US Food and Drug Administration. Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations, March 2003.
3. S. D. Patterson, N. M.-D. Zariffa, T. H. Montague, and K. Howland. Non-traditional study designs to demonstrate average bioequivalence for highly variable drug products. Eur. J. Pharm. Sci. 57:663–670 (2001).
4. L. Z. Benet. Therapeutic Considerations of Highly Variable Drugs. Meeting of FDA Committee for Pharmaceutical Science, October 6, 2006. http://www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_2_files/frame.htm (accessed 04/04/2007).
5. D. J. Schuirmann. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J. Pharmacokinet. Biopharm. 15:657–680 (1987).