An overview of stability studies

Journal of Food and Drug Analysis

Volumn 4, Issue 2, 1996, Pages 104-106

  Ju, Huey Lin ^a   Chow, Shein Chung ^a  

^a NATIONAL CHENGCHI UNIVERSITY   (Taiwan)

Author keywords

Accelerating testing; Degradation curve; Expiration dating period; Shelf life

Indexed keywords

EID: 5344269477     PISSN: 10219498     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (34)

1. EC. 1987. Stability Tests of Active Substances and Finished Products. Rules Governing Medical Products in the European Community, Brussels, Belgium.
2. MHW. 1991. Stability Guidelines. Ministry of Health and Welfare, Tokyo.
3. ICH. 1993. Stability Testing of New Drug Substances and Products. Tripartite International Conference on Harmonization Guideline.
4. WHO. 1993. World Health Organization Guidelines on Stability Testing of Pharmaceutical Products Containing Well-Established Drug Substances in Conventional Dosage Forms. Reference WHO/PHARM/92, 158/Rev.4. WHO, Geneva.
5. USP/NF. 1990. The United States Pharmacopeia XXII and the National Formulary XVII. The United States Pharmacopeial Convention, Rockville, Md.
6. Bohidar, N. R., Peace, K. 1988. Pharmaceutical Formulation Development. Chapter 4 in Biopharmaceutical Statistics for Drug Development, ed. Peace, K. Marcel Dekker, New York, pp. 149-229.
7. Davies, O. L., and Hudson, H. E. 1981. Stability for Drugs: Accelerated Storage Tests. Chapter 15 in Statistics in the Pharmaceutical Industry, ed. Buncher, C. R., and Tsay, J. Y. Marcel Dekker, New York, pp. 355-395.
8. Carstensen, J. T. 1990. Drug Stability. Marcel Dekker, New York.
9. Kirkwood, T. B. L. 1977. Predicting the Stability of Biological Standards and Products. Biometrics, 33: 736-742.
10. Montgomery, D.C. 1991 . Design and Analysis of Experiments, 3rd ed. John Wiley & Sons, New York.
11. Chow, S. C. 1992. Statistical Design and Analysis of Stability Studies. Presented at the 48th Conference on Applied Statistics, Atlantic City, N.J.
12. Helboe, P. 1992. New Design for Stability Testing Programs: Matrix or Factorial Designs Authorities' Viewpoint on the Predictive Value of Such Studies. Drug Info. J., 26: 629-634.
13. Lin, T. Y. D. 1994. Applicability of Matrixing and Bracketing Approach to Stability Study Design. Presented at the 4th ICSA Applied Statistics Symposium, Food and Drug Administration, Rockville, Md.
14. Nordbrock, E. 1992. Statistical Comparison of Stability Study Designs. J. Biopharm. Stat., 2: 91-113.
15. Ju, H. L. and Chow, S.C. 1995. On Statistical Design of Stability Studies, J. of Biopharm. Stat. 5: 201-214.
16. Chow, S. C. and Shao, J. 1989. Test for Batch-to-Batch Variation in Stability Analysis. Stat. Med., 8: 883-890.
17. Chow, S. C. and Shao, J. 1991. Estimating Drug Shelf-life with Random Batches. Biometrics. 47: 1071-1079.
18. Liu, J. P. 1992. On Analysis of Stability Data, Presented at the 48th Conference on Applied Statistics, Atlantic City, N.J.
19. Murphy, J. R. and Weisman, D. 1990. Using Random Slopes for Estimating Shelf-life. Proceedings of the Biopharmaceutical Section of the American Statistical Association, pp. 196-203.
20. Ho, C. H., Liu, J. P. and Chow, S. C. 1992. On Analysis of Stability Data, Proceedings of the Biopharmaceutical Section of the American Statistical Association, pp. 198-203.
21. Shao, J. and Chow, S. C. 1994. Statistical Inference in Stability Analysis, Biometrics, 50: 753-763.
22. Chow, S. C. and Wang, S. G. 1994. On the Estimation of Variance Components in Stability Analysis. Commun. Stat. Theory Methods, 23(1): 289-303.
23. Ruberg , S. and Stegeman, J. W. 1991. Pooling Data for Stability Studies: Testing the Equality of Batch Degradation Slopes. Biometrics, 47: 1059-1069.
24. Ruberg, S. and Hsu, J. 1992. Multiple Comparison Procedures for Pooling Batches in Stability Studies. Technometrics, 34: 465-472.
25. Chow, S. C. and Liu, J. P. 1992. Design and Analysis of Bioavailability and Bioequivalence Studies. Marcel Dekker, New York.
26. Norbrock, E. 1994. Design and Analysis of Stability Studies. Proceedings of the American Statistical Association, pp. 291-294.
27. Grimes, J.A. and Foust, L. B. 1994. Establishing Release Limits with a Random Slopes Stability Model. Proceedings of the American Statistical Association, pp. 498-502.
28. Chen, J.J., Hwang, J.S. and Tsong, Y. 1995. Estimation of the Shelf-life of Drugs with Mixed Effects Models. J. Biopharm. Stat., 5: 131-140.
29. Copeland, K.A.F. and Nelson, P.R. 1995. Statistical Modeling of Accelerated Stability Studies. Submitted to Biometrics.
30. Sun, Y., Chow, S.C., Li, G. and Chen, K.W. 1995. Assessing Distributions of Estimated Drug Shelf-lives in Stability Analysis. Submitted to Biometrics.
31. Chow, S.C. and Pong, A. 1995. Current Issues in Regulatory Requirements of Drug Stability. pp. 75-86.
32. Chow, S. C. and Liu, J. P. 1995. Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls and Stability. Marcel Dekker, New York.