References
- Chen, M. L., Patnaik, R., Hauck, W. W., Schuirmann, D. F., Hyslop, T., Williams, R. (2000). An individual bioequivalence criterion: Regulatory considerations. Statistics in Medicine 19:2821–2842.
- Choi, K., Hong, T., Lee, J. (2014). On comparison of SAS codes with GLM and MIXED for the crossover studies with QT interval data. Translational and Clinical Pharmacology 22(2Special Issue on Biosimilarity Assessment):78–82.
- Chow, S. C., Chang, M. (2011). Adaptive Design Methods in Clinical Trials, 2nd ed. New York: Chapman and Hall/CRC Press, Taylor & Francis.
- Chow, S. C., Liu, J. P. (2008). Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd ed. New York: Chapman and Hall/CRC Press, Taylor & Francis.
- Chow, S. C., Song, F. Y., Chen, M. (2016). Some thoughts on drug interchangeably. Journal of Biopharmaceutical Statistics 26(1):178–186.
- Chow, S. C., Xu, H. L., Endrenyi, L., Song, F. Y. (2015). A new scaled criterion for drug interchangeability. Chinese Journal of Pharmaceutical Analysis 35(5):844–848.
- Cookbook SAS Codes for Bioequivalence Test in 2×2×2 Crossover Design. (2012). Cary, NC: SAS Institute.
- Endrenyi, L., Taback, N., Tothfalusi, L. (2000). Properties of the estimated variance component for subject-by-formulation interaction in studies of individual bioequivalence. Statistics in Medicine 19:2867–2878.
- FDA. (2001). Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. Rockville, MD: Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
- FDA. (2003). Guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products – General Considerations[s]. Rockville, MD: Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
- Hauck, W. W., Hyslop, T., Chen, M. L., Patnaik, R., Williams, R. L., the FDA P/IBE working group. (2000). Subject-by-formulation interaction in bioequivalence: conceptual and statistical issues. Pharmaceutical Research 17(4):375–380.