References
- Berman J., Planchard J. A. Blend uniformity and unit dose sampling. Drug Dev. Ind. Pharm. 1995; 21(11)1257–1283
- Bowker A. H. Computation of factors for tolerance limits on a normal distribution when the sample is large. Ann. Math. Statistics 1946; 17: 238
- Bowker A. H. Selected Techniques of Statistical Analysis for Scientific and Industrial Research and Production and Management Engineering, C. Eisenhart, M. W. Hastay, W. A. Wallis. McGraw-Hill, New York 1947
- Carstensen J. T., Modes C. T. Sampling in blending validation. Drug Dev. Ind. Pharm. 1993; 19(20)2699–2708
- Chow Shein-Chung, Liu Jen-Pei. Statistical Design and Analysis in Pharmaceutical Science—Validation, Process Controls, and Stability. Marcel Dekker, New York 1993
- Cowdery S., Michaels T. An evaluation of the proposed dose uniformity acceptance sampling plan for tablets and capsules, Pharmacopeial Forum. The United States Pharmacopeial Convention, Inc. 1980; 614–618
- Danziger L., Davis S. A. Tables of distribution-free tolerance limits. Ann. Math. Statistics 1964; 35: 1361–1365
- Doming W. E. On the use of judgment samples. Rep. Statistical Appl. Jpn. Union Sci. Eng. 1976; 23: 25–31
- Dietrick J. M. Food and drug administration recommendations on validation issues. Regulatory Affairs 1993; 5: 363–366
- Dudewicz E. J. Basic statistical methods. Juran's Quality Control Handbook, 4th ed., J. M. Juran, F. M. Gryna. McGraw-Hill, New York 1988
- Eisenhart C., Hastay M. W., Wallis W. A. Techniques of Statistical Analysis. McGraw-Hill, New York 1947
- Ellison B. E. On two-sided tolerance intervals for a normal distribution. Ann. Math. Statistics 1946; 35: 762–772
- Gardiner D. A., Hull N. C. An approximation of two-sided tolerance limits for normal populations. Technometrics 1966; 8: 115–122
- Grant E. L., Leavenworth R. S. Statistical Qualify Control, 6th ed. McGraw-Hill, New York 1988
- Hahn G. Statistical intervals for a normal population, Part II: Formulas, assumptions, some derivations. J. Quality Technol. 1970; 2: 195–206
- Hahn G. J., Meeker W. Q. Statistical Intervals— A Guide for Practitioners. John Wiley & Sons, New York 1991
- Howe W. G. Two-sided tolerance limits for normal populations—Some improvements. J. Amer. Statist. Assoc. 1969; 64: 610–620
- Lieberman A. Tables for the Determination Two-sided Tolerance Limits for the Normal Distribution. Bureau of Ships, Navy Department, Washington, DC 1957, Report No. 373–17(55)
- Lord A. G. Content uniformity in tablets: A literature review. Pharm. Technol. 1987; 64–70, September
- Mouradian G. Tolerance limits for assemblies and engineering relationships. ASQC Technical Conference Trans., Milwaukee, 1966; 598–606
- Nicolette B. P. 1, Statistical implications of the USP XXIII Content Uniformity Test. Pharmacopeial Forum. The United States Pharmacopeial Convention, Inc. 1981; 878–887
- Odeh R. E. Tables of two-sided tolerance factors for a normal distribution. Commun. Statist. Simul. Comp. B 1978; 7: 183–201
- Odeh R. E., Owen D. B. Tables for Normal Tolerance Limits, Sampling Plans, and Screening. Marcel Dekker, New York 1980
- Patel J. K. Tolerance intervals—a review. Commun. Statist. Theory Methods 1986; 15: 2719–2762
- Tietjen G. L., Johnson M. E. Exact statistical tolerance limits for sample variances. Technometrics 1979; 21: 107–110
- Wald A., Wolfowitz J. Tolerance limits for a normal distribution. Ann. Math. Statistics 1946; 17: 208–215
- Weissberg A., Beatty G. H. Tables of tolerance limit factors for normal distributions. Technometrics 1960; 2: 483–500, Errata 3, 576–577