Overview of stability study designs

Journal of Biopharmaceutical Statistics

Volumn 13, Issue 3, 2003, Pages 337-354

  Lin, Tsae Yun Daphne ^a,b   Chen, Chi Wan ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Center for Drug Evaluation and Research   (United States)

Author keywords

Bracketing design; Matrixing design; Optimality criteria; Shelf life estimation

Indexed keywords

DRUG;

ACCURACY; ANALYTIC METHOD; DRUG DESIGN; DRUG QUALITY; DRUG STABILITY; FOOD AND DRUG ADMINISTRATION; PRACTICE GUIDELINE; PRIORITY JOURNAL; REVIEW; SAMPLING; SHELF LIFE; STATISTICAL ANALYSIS;

CHEMISTRY, PHARMACEUTICAL; DRUG STABILITY; DRUG STORAGE; GUIDELINES; MODELS, STATISTICAL; RESEARCH DESIGN; TIME FACTORS;

EID: 0041633675     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120022759     Document Type: Review

References (26)

1. Ahn, H., Chen, J., Lin, T. D. (1997). A two-way analysis of covariance model for classification of stability data. Biom. J. 39(5):559-576.
2. Carstensen, J. T., Franchini, M., Ertel, K. (1992). Statistical approaches to stability protocol design. J. Pharm. Sci. 81(3):303-308.
3. Chambers, D. (1996). Matrixing/bracketing US industry views. In: Proceedings from EFPIA Symposium: Advanced Topics in Pharmaceutical Stability Testing Building on the ICH Stability Guideline, EFPIA, Brussels.
4. Chen, C. (1996). US FDA's perspective of matrixing and bracketing. In: Proceedings from EFPIA Symposium: Advanced Topics in Pharmaceutical Stability Testing Building on the ICH Stability Guideline, EFPIA, Brussels.
5. Chen, J., Ahn, H., Tsong, Y. (1997). Shelf life estimation for multi-factor stability studies. Drug Inf. J. 31(2):573-587.
6. Chow, S. C.; Liu, J. P., eds. (1995). Statistical Designs and Analysis in Pharmaceutical Science. New York: Marcel Dekker.
7. Draft ICH Consensus Guideline. (2003). Q1E Stability Data Evaluation. Food and Drug Administration; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Rockville, MD.
8. FDA. (1987). Guidelines for Submitting Documentation for the Stability of Human Drugs and Biologics. Rockville MD, USA: Food and Drug Administration, Center for Drugs and Biologics, Office of Drug Research and Review.
9. Fairweather, W. R., Lin, T. D. (1999). In: Mazzo, D., ed. Statistical and Regulatory Aspects of Drug Stability Studies: An FDA Perspectives. International Stability Testing. Interpharm Press, Inc.: Illinois, pp. 107-132.
10. Fairweather, W., Lin, T. D., Kelly, R. (1995). Regulatory, design, and analysis aspects of complex stability studies. J. Pharm. Sci. 84(11):1322-1326.
11. Fedorov, V. V. (1972). In: Studden, W. J., Klimko, E. M., eds. Theory of Optimal Experiments. New York: Academic Press.
12. Golden, M. H., Cooper, D., Riebe, M., Carswell, K. (1996). A matrixed approach to long-term stability testing of pharmaceutical products. J. Pharm. Sci. 86:240-244.
13. Guidance for Industry: ICH. (2003a). Q1A(R2) Stability Testing of New Drug Substances and Products. Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Rockville, MD.
14. Guidance for Industry: ICH. (2003b). Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products. Food and Drug Administration, Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research, Rockville, MD.
15. Helboe, P. (1992). New designs for stability testing programs: matrix or factorial designs. Authorities viewpoint on the predictive value of such studies. Drug Inf. J. 26:629-634.
16. Helboe, P. (1999). In: Mazzo, D., ed. Matrixing and Bracketing Designs for Stability Studies: An Overview from the European Perspective, International Stability Testing. Interpharm Press, Inc.: Illinois, pp. 135-160.
17. Ju, H. L., Chow, S. C. (1995). On stability designs in drug shelf life estimation. J. Biopharm. Stat. 5(2):201-214.
18. Kiefer, J. (1959). Optimal experimental designs. J. R. Stat. Soc. Ser. B(21):272-319.
19. Lin, T. D. (1994). Applicability of matrix and bracket approach to stability study design. In: Proceedings of the American Statistical Association Biopharmaceutical Section, 142-147.
20. Lin, T. D. (1999a). Statistical considerations in bracketing and matrixing. In: Proceedings from IBC Bracketing and Matrixing Conference, London.
21. Lin, T. D. (1999b). Study Design, Matrixing and Bracketing. Arlington, VA: AAPS Workshop on Stability Practices in the Pharmaceutical Industry - Current Issues.
22. Lin, T. D., Fairweather, W. R. (1997). Statistical design (bracketing and matrixing) and analysis of stability data for the US market. In: Proceedings from IBC Stability Testing Conference, London.
23. Nordbrock, E. (1992). Statistical comparison of stability study designs. J. Biopharm. Statist. 2:91-113.
24. Shao, J., Chow, S. C. (1994). Statistical inference in stability analysis. Biometrics 50(3):753-763.
25. Yoshioka, S. (1999). In: Mazzo, D., ed. Current Application in Japan of the ICH Stability Guidelines: Does Japanese Registration Require More than Others Do? International Stability Testing. Interpharm Press, Inc.: Illinois, pp. 255-264.
26. Yoshioka, S., Aso, Y., Kojima, S. (1997). Assessment of shelf-life equivalence of pharmaceutical products. Chem. Pharm. Bull. 45:1482-1484.