GitHub

Reference

Bioequivalence

  • Chow S-C, Liu J-P. Design and analysis of bioavailability and bioequivalence studies. 3. Boca Raton: CRC; 2009.

  • Hauschke D, Steinijans V, Pigeot I. Bioequivalence studies in drug development. Methods and applications. Chichester: Wiley; 2007.

  • Rani S, Pargal A. Bioequivalence: an overview of statistical concepts. Ind J Pharmacol. 2004;36:209–16.

  • Bolton S and Bon C. Statistical consideration: alternate designs and approaches for bioequivalence assessments. In: Kanfer I and Shargel L, editors. Generic Drug Product Development. Bioequivalence Issues. New York: Informa Healthcare; 2008. p. 123–141.

Data set

  • Fuglsang A, Schütz H, Labes D. Reference datasets for bioequivalence trials in a two-group parallel design. AAPS J. 2015 Mar;17(2):400-4. doi: 10.1208/s12248-014-9704-6. Epub 2014 Dec 9. PMID: 25488055; PMCID: PMC4365103.

  • Schütz H, Labes D, Fuglsang A. Reference datasets for 2-treatment, 2-sequence, 2-period bioequivalence studies. AAPS J. 2014 Nov;16(6):1292-7. doi: 10.1208/s12248-014-9661-0. Epub 2014 Sep 12. PMID: 25212768; PMCID: PMC4389751.

  • Schütz H, Labes D, Tomashevskiy M, la Parra MG, Shitova A, Fuglsang A. Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits. AAPS J. 2020 Feb 7;22(2):44. doi: 10.1208/s12248-020-0427-6. PMID: 32034551.