1. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research Guidance for industry: bioavailability and bioequivalence studies submitted in NDAs or INDs-general considerations http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm389370.pdf
2. European Medicines Agency Guideline on the investigation of bioequivalence http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2010/01/WC500070039.pdf
3. Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence;Tothfalusi;Clin Pharmacokinet,2009
4. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research Guidance for industry: statistical approaches to establishing bioequivalence https://www.fda.gov/downloads/drugs/guidances/ucm070244.pdf
5. Two-stage designs in bioequivalence trials;Schütz;Eur J Clin Pharmacol,2015