References
- Arnold, B. C., and Shavelle R. M. (1998), “Joint Confidence Sets for the Mean and Variance of a Normal Distribution,” The American Statistician, 52, 133–140.
- ASTM E2810-11e2 (2011), Standard Practice for Demonstrating Capability to Comply with the Test for Uniformity of Dosage Units, West Conshohocken, PA: ASTM International, available at www.astm.org.
- Bergum, J. S. (1990), “Constructing Acceptance Limits for Multiple Stage Tests,” Drug Development and Industrial Pharmacy, 16, 2153–2166. DOI: 10.3109/03639049009023647.
- Chiang, C., Chen, C. F., Huang, M. Y., and Liu, J. P. (2012), “An Inferential Procedure for the Probability of Passing the USP Dissolution Test,” Pharmaceutical Statistics, 11, 32–38. DOI: 10.1002/pst.492.
- Chow, S. C., and Liu, J. P. (1995), Statistical Design and Analysis in Pharmaceutical Science, New York: Marcel Dekker.
- Chow, S. C., Shao, J., and Wang, H. (2002), “Probability Lower Bounds for USP/NF Tests,” Journal of Biopharmaceutical Statistics, 12, 79–92. DOI: 10.1081/bip-120005781.
- Frey, J., Marrero O., and Norton, D. (2009), “Minimum-Area Confidence Sets for a Normal Distribution,” Journal of Statistical Planning and Inference, 139, 1023–1032. DOI: 10.1016/j.jspi.2008.06.005.
- Genz, A. (1992), “Numerical Computation of Multivariate Normal Probabilities,” Journal of Computational and Graphical Statistics, 1, 141–149.
- Genz, A. (1993), “Comparison of Methods for the Computation of Multivariate Normal Probabilities,” Computing Science and Statistics, 25, 400–405.
- LeBlond, D., and Mockus, L. (2014), “The Posterior Probability of Passing a Compedial Standard, Part1: Uniformity of Dosage Units,” Statistics in Biopharmaceutical Research, 6, 270–286. DOI: 10.1080/19466315.2014.928231.
- Lindgren, B. W. (1968), Statistical Theory, New York: The Macmillan Company.
- Lewis, R. A., and Fan, A. (2016), “Improved Acceptance Limits for ASTM Standard E2810,” Statistics in Biopharmaceutical Research, 8, 40–48. DOI: 10.1080/19466315.2015.1093959.
- Mood, A. M., Boes, D. C., and Graybill, F. A. (1974), Introduction to the Theory of Statistics, NJ: McGraw-Hill.
- R Core Team (2018), R: A Language and Environment for Statistical Computing, Vienna, Austria: R Foundation for Statistical Computing, available at https://www.R-project.org/.
- United States Pharmacopeia and National Formulary. (2005), The United States Pharmacopeia 28 and the National Formulary 23, Rockville, MD: The United States Pharmacopeial Convention.
- Wang, H. (2007), “Estimation of the Probability of Passing the USP Dissolution Test,” Journal of Biopharmaceutical Statistics, 17, 407–413. DOI: 10.1080/10543400701199536.