References
- Chen, Y. I., Huang, C. S. (2009). Multiple testing for bioequivalence with pharmacokinetic data in 2 × 2 crossover designs. Statistics in Medicine 28:3567–3579.
- Chow, S. C., Liu, J. P. (1999). Design and Analysis of Bioequivalence and Bioavailability Studies, 3rd ed. Boca Raton, FL: Chapman & Hall/CRC Biostatistics Series
- EMEA. (2010). Guidance on the Testing of Bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1
- FDA. (1995). Guidance for Industry: Immediate Release Solid Oral Dosage Forms. Scale-Up and Postapproval Changes: Chemistry, Manufacturing and Controls, In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation. U.S. Department of Health and Human Services, FDA. Center of Drug Evaluation and Research (CDER): Rockville, MD. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070636.pdf.
- FDA. (2006). Guidance for Industry: Bioequivalence Guidance. http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/ucm052363.pdf.
- Liao, J. (2005). Comparing the concentration curves directly in a pharmacokinetics, bioavailability/bioequivalence study. Statistics in Medicine 24:883–891.
- Lunn, D. J., Thomas, A., Best, N., Spiegelhalter, D. (2000). WinBUGS – a Bayesian modelling framework: Concepts, structure, and extensibility. Statistics and Computing 10:325–337.
- Mauger, D. T., Chinchilli, V. M. (2000). An alternative index for assessing profile similarity in bioequivalence trials. Statistics in Medicine 19:2855–2866.
- Novick, S., Shen, Y., Yang, H., Peterson, J., LeBlond, D., Altan, S. (2015). Dissolution curve comparisons through the F2 parameter, a Bayesian extension of the f2 statistic. Journal of Biopharmaceutical Statistics 25(2):351–371.
- Novick, S., Yang, H., Peterson, J. (2012). A Bayesian approach to parallelism testing. Statistics in Biopharmaceutical Research 4(4):357–374.
- Plummer, M. (2003). JAGS: A program for analysis of Bayesian graphical models using Gibbs sampling, Proceedings of the 3rd International Workshop on Distributed Statistical Computing (DSC 2003), March 20–22, Vienna, Austria. ISSN 1609-395X.
- Stan Development Team. (2014). Stan Modeling Language Users Guide and Reference Manual, version 2.4. http://mc-stan.org.
- Westlake, W. J. (1988). Bioavailability and bioequivalence of pharmaceutical formulations. In Biopharmaceutical Statistics for Drug Development. Peace, K. E. (ed.). Marcel Dekker, New York.