References
- Bailer, A. J. (1988). Testing for the equality of area under the curves when using destructive measurement techniques. Journal of Pharmacokinetics and Biopharmaceutics 16(3):303–309.
- CDER Drug and Biologic Calendar Year Approvals as of December 31, 2009. Retrieved from http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/UCM374751.pdf.
- Mager, H., Göller, G. (1995 May 15–30). Analysis of pseudo-profiles in organ pharmacokinetics and toxicokinetics. Statistics in Medicine 14(9–10):1009–1024.
- Shen, M. (2008). Statistical review for application number 50818, Center for Drug Evaluation and Research, Food and Drug Administration.
- Takemoto, S., Yamaoka, K., Nishikawa, M., Takakura, Y. (2006). Histogram analysis of pharmacokinetic parameters by bootstrap resampling from one-point sampling data in animal experiments. Drug Metabolism and Pharmacokinetics 21(6):458–464.
- U.S. Food and Drug Administration. (1992 July). Center for Drug Evaluation and Research, Guidance for Industry: Statistical Procedures for Bioequivalence Studies Using a Standard Two-Treatment Crossover Design.
- U.S. Food and Drug Administration. (2001 Jan). Center for Drug Evaluation and Research, Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. Retrieved from http://www.fda.gov/downloads/Drugs/Guidances/ucm070244.pdf.
- U.S. Food and Drug Administration. Center for Drug Evaluation and Research, Draft Guidance on Dexamethasone; Tobramycin. Recommended in December 2009. Revised in June 2012 and June 2013.