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Journal of Quality Technology
A Quarterly Journal of Methods, Applications and Related Topics
Volume 3, 1971 - Issue 4
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Articles

Some Statistical Aspects of Pharmaceutical Content Uniformity

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Pages 170-178 | Published online: 27 Feb 2018

References

Periodicals

  • Aroian, L. A., “The Probability Function of a Product of Two Normally Distributed Variables,”, Annals of Mathematical Statistics, Vol. 18, No. 2, June 1947, pp. 265–271.
  • Breunig, H. Latham and King, E. P., “Acceptance Sampling of Finished Pharmaceutical Products,”, Journal of Pharmaceutical Sciences, Vol. 51, No. 12, December 1962, pp. 1187–1194.
  • Comer, J. P.; Breunig, H. L.; Broadlick, D. E.; and Sampson, C. B., “Estimation of Mean Potency and Content Uniformity of Tablets: A New Approach,”, Journal of Pharmaceutical Sciences, Vol. 59, No. 2, February 1970, pp. 210–214.
  • Craig, C. C., “On the Frequency Functions of AT,”, Annals of Mathematical Statistics, Vol. 7, No. 1, March 1936, pp. 1–15.
  • Dunnett, C. W. and Crisafio, R., “The Operating Characteristics of Some Official Weight Variation Tests for Tablets,”, Journal of Pharmacy and Pharmacology, Vol. 7, 1955, pp. 314–327.
  • French, W. N.; Matsui, F.; Cook, Denys; and Levi, Leo, “Pharmacopeial Standards and Specifications for Bulk Drugs and Solid Oral Dosage Forms, Similarities, and Differences,”, Journal of Pharmaceutical Sciences, Vol. 56, No. 12, December 1967, pp. 1622–1641.
  • Goodman, L. A., “On the Exact Variance of Products,”, American Statistical Association Journal, Vol. 55, No. 292, December 1960, pp. 708–713.
  • Lieberman, G. J. and Resnikoff, G. J., “Sampling Plans for Inspection by Variables,”, American Statistical Association Journal, Vol. 50, No. 270, June 1955, pp. 457–516.
  • Olson, T. N. T. and Lee, I., “Applications of Statistical Methodology in Quality Control Functions of the Pharmaceutical Industry,”, Journal of Pharmaceutical Sciences, Vol. 55, No. 1, Jan. 1966, pp. 1–14.
  • Owen, D. B., “Control of Percentages in Both Tails of the Normal Distribution,”, Technometrics, Vol. 6, No. 4, Nov. 1964, pp. 377–387.
  • Owen, D. B., “A Special Case of a Bivariate Noncentral t-distribution,”, Biometrika, Vol. 52, Nos. 3 and 4, December 1965, pp. 437–446.
  • Owen, D. B., “One-sided Variables Sampling Plans,”, Industrial Quality Control, Vol. 23, March 1966, pp. 450–455.
  • Owen, D. B., “Variables Sampling Plans Based on the Normal Distribution,”, Technometrics, Vol. 9, No. 3, Aug. 1967, pp. 417–423.
  • Quenouille, M. H., “Approximate Tests of Correlation in Time Series,”, Royal Statistical Society Journal Series B, Vol. 11, 1969, pp. 68–84.
  • Quenouille, M. H., “Notes on Bias in Estimation,”, Biometrics, Vol. 43, 1956, pp. 353–360.
  • Roberts, C., “Fill Weight Variation Release and Control of Capsules, Tablets, and Sterile Solids,”, Technometrics, Vol. 11, No. 1, Feb. 1969, pp 101–176.
  • Sampson, C. B.; Breunig, H. L.; Comer, J. P.; and Broadlick, D. E., “Characterization of the Content Uniformity Plan,”, Journal of Pharmaceutical Sciences, Vol. 59, No. 11, November 1970, pp. 1653–1655.
  • Sampson, C. B.; Breunig, H. L.; Comer, J. P.; and Broadlick, D. E., “A Characterization of the USP XVIII Content Uniformity Plan,” Journal of Pharmaceutical Sciences, A Communication to the Editor, Vol. 60, No. 60, June 1971, pp. 955–956.
  • Welch, B. L., “On Linear Combinations of Variances,”, American Statistical Association Journal, Vol. 51, No. 273, March 1956, pp. 132–148.
  • Wald, A. and Wolfowitz, J., “Tolerance Limits for a Normal Distribution,”, Annals of Mathematical Statistics, Vol. 17, No. 2, June 1946, pp. 208–215.
  • Zimmer, W. J. and Burr, I. W., “Variables Sampling Plans Based on Non-normal Populations,”, Industrial Quality Control, Vol. 20, No. 1, July, 1963, pp. 18–26.

Books

  • Bowker, Albert H. and Goode, Henry P., Sampling Inspection by Variables, McGraw-Hill Book Company, New York, N. Y., 1952.
  • Duncan, A. J., Quality Control and Industrial Statistics, Richard D. Irwin, Inc., Homewood, Ill., 1959.
  • Fisher, R. A., Statistical Methods and Scientific Inference, T. and A. Constable Ltd., Great Britain, 1956.
  • Hald, A., Statistical Theory with Engineering Applications, John Wiley and Sons, Inc., New York, N. Y., 1952.
  • National Formulary, 13th ed., Mack Publishing Co., Easton, Pa., 1970, p. 798.
  • Statistical Research Group, Columbia University, Sampling Inspection, Principles, Procedures, and Tables for Single, Double, and Sequential Sampling in Acceptance Inspection and Quality Control, McGraw-Hill Book Co., New York, N. Y., 1948.
  • United States Pharmacopeia, 18th rev., Mack Publishing Co., Easton, Pa., 1970, p. 930.

Pamphlets

  • Burr, I. W., “On the Distribution of Products, Quotients, and Other Functions of Random Variables,” Chemical Division (American Society for Quality Control) CD News, Vol. 10 (Special Issue.) Technical Supplement, October, 1964, pp. 7–11.
  • DeZur, R. S. and Donahue, J. D., “On Products and Quotients of Random Variables,” Aeronautical Research Laboratory, Technical Report 71, 1965.
  • “Sampling Procedures and Tables for Inspection by Attributes,” MIL-STD-105D, April 1963, Department of Defense, Washington, D.C.
  • “Sampling Procedures and Tables for Inspection by Variables for Percent Defective,” MIL-STD-414, June 1957, Department of Defense, Washington, D.C.

Transactions

  • Breunig, H. Latham, “It's in the Weight,” Annual Technical Conference Transactions, American Society for Quality Control, 1968, pp. 23–30.

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