10
Views
6
CrossRef citations to date
0
Altmetric
Research Article

The Application of Multiresponse Estimation to Drug Stability Studies

, , &
Pages 2823-2838 | Published online: 20 Oct 2008

References

  • Munguia O., Parrilla M. J., Llabres M. The Statistical Interpretation of Accelerated Degradation Studies in Solutions. J. Paren. Sci. & Tech 1986; Vol. 40.(No. 3)100–103
  • Norwood T. Statistical Analysis of Pharmaceutical Stability Data. Drug Dev. & Ind. Pharm 1986; Vol. 12.(No. 4)553–560
  • Bondreau C. F. Handling Stability Data Via the Computer. Drug Dev. & Ind. Pharm 1984; Vol 10(No. 8 & 9)1527–1547
  • Kmetec V., Mrhar A., Karba R., Kozjek F. Evaluation of Drug Stability Data by Analog-Hybrid Computer: Application to Lorazepam. Int. J. Pharm 1984; Vol. 21: 211–218
  • King S. P., Kung M., Fung H. Statistical Prediction of Drug Stability Based on Nonlinear Parameter Estimation. J. Pharm. Sci 1984; Vol. 73(No. 5)657–662
  • Bolton S. Factorial Designs in Pharmaceutical Stability Studies. J. Pharm. Sci 1983; Vol. 72(No. 4)362–366
  • Nelson P. R. Stability Prediction Using the Arrhenius Model. Computer Programs in Biomed 1983; Vol. 16: 55–60
  • Tucker I. G., Owen W. R. Estimation of All Parameters from Nonisothermal Kinetic Data. J. Pharm. Sci 1982; Vol. 71(No. 9)969–974
  • Yang W. Statistical Treatment of Stability Data. Drug Dev. & Ind. Pharm 1981; Vol. 7(No. 1)63–77
  • Davies O. L., Budgett D. A. Accelerated Storage Tests on Pharmaceutical Products: Effect of Error Structure of Assay and Errors in Recorded Temperature. J. Pharm. Pharmacol 1980; Vol. 32: 155–159
  • Ogden J. E. A Weibull Shelf-Life Model for Pharmaceuticals. Pharm. Tech October, 1978; 45–49; 58
  • Marubini E., Milani S., Catalucci R. Criteria for Assigning the Order of Degradation Rate in the Accelerated Stability Tests: Statistical Aspects. II Farmaco (Ed. Pr.) 1978; Vol. 33(No. 3)95–110
  • Thiers R. E., Wu G. T., Reed A. H., Oliver L. K. Sample Stability: A Suggested Definition and Method of Determination. Clin. Chem 1976; Vol. 22(No. 2)176–183
  • Carstensen J. T., Su K. S. E. Statistical Aspects of Arrhenius Plotting. Bull. Paren. Drug Assoc 1971; Vol. 25(No. 6)287–302
  • Bentley D. L. Statistical Techniques in Predicting Thermal Stability. J. Pharm Sci 1970; Vol. 59(No. 4)464–468
  • Kendall M., Stuart A. The Advanced Theory of Statistics4th Edition. MacMillan. 1977; Vol. 1: 246–247
  • Draft Guidelines For Stability Studies for Human Drugs and Biologies. Food and Drug Administration. August, 1985, Docket No. 84D-0115
  • SAS User's Guide: BasicsVersion 5 Edition. SAS Institute. 1985; 260
  • SAS User's Guide: StatisticsVersion 5 Edition. SAS Institute. 1985; 575–606

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.