References for Bioequivalence

Anderson and Hauck (1983). A new procedure for testing equivalence in comparative bioavailability and other clinical trials. Commun Stat Theory Methods, 12:2663–92.

Chow and Liu (2nd ed. 2000 or 3rd ed. 2009). Design and Analysis of Bioavailability and Bioequivalence Studies, Marcel Dekker, Inc.

Hauschke, Steinijans, Diletti, Schall, Luus, Elze and Blume (1994). Presentation of the intrasubject coefficient of variation for sample size planning in bioequivalence studies. Int J Clin Pharm Ther 32(7): 376–378.

Hyslop, Hsuan and Holder (2000). A small sample on interval approach to assess individual bioequivalence. Statist Medicine 19:2885–97.

Schuirmann (1987). 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.

Snedecor and Cochran (1989). Statistical Methods, 8th edition, Iowa State Press.

US FDA Guidance for Industry (March 2003). Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations.

US FDA Guidance for Industry (January 2001). Statistical Approaches to Establishing Bioequivalence.

Phillips, K. F. (1990). Power of the Two One-Sided Tests Procedure in Bioequivalence. Journal of Pharmacokinetics and Biopharmaceutics 18: 137–144.

Diletti, E., Hauschke, D., and Steinijans, V. W. (1991). Sample size determination for bioequivalence assessment by means of intervals. Int. J. of Clinical Pharmacology, Therapy and Toxicology 29: 1–8.

Owen, D. B. (1965). A Special case of a bivariate noncentral t-distribution. Biometrika 52: 437–446.


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