Comparing distributions of shelf lives for drug products with two components under different designs

Journal of Biopharmaceutical Statistics

Volumn 12, Issue 3, 2002, Pages 277-293

  Pong, Annpey ^a   Raghavarao, Damaraju ^b  

^a NOVARTIS PHARMA AG   (Switzerland)

^b TEMPLE UNIVERSITY   (United States)

Author keywords

Bracketing design; Degradation; Expiration dating period; Matrixing design; Shelf life; Stability

Indexed keywords

CONJUGATED ESTROGEN; ETHINYLESTRADIOL PLUS LEVONORGESTREL; ORAL CONTRACEPTIVE AGENT; PREMARINE; UNCLASSIFIED DRUG;

ARTICLE; DRUG ANALYSIS; DRUG DEGRADATION; DRUG DESIGN; DRUG DEVELOPMENT; DRUG RESEARCH; DRUG STABILITY; PRIORITY JOURNAL; SHELF LIFE; SIMULATION;

ALGORITHMS; CHEMISTRY, PHARMACEUTICAL; DRUG COMBINATIONS; DRUG DESIGN; DRUG STABILITY; MODELS, STATISTICAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0036428722     PISSN: 10543406     EISSN: None     Source Type: Journal    
DOI: 10.1081/BIP-120014559     Document Type: Article

References (15)

1. USP/NF. The United States Pharmacopeia XXII and the National Formulary XVII; The United States Pharmacopeial Convention: Rockville, MD, 2000.
2. ICH. Stability testing of new drug substances and products. Tripartite International Conference on Harmonization Guideline, September 1, 1993.
3. FDA. Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics; Center for Drugs and Biologics, Office of Drug Research and Review, Food and Drug Administration: Rockville, MD, 1987.
4. Habs, M. Herbal products: Advances in preclinical and clinical development. Drug Inf. J. 1999, 33, 993-1001.
5. Chow, S.C.; Shao, J. Statistics in Drug Research-Methodology and Recent Development; Marcel Dekker: New York, 2002.
6. DeWoody, K.; Raghavarao, D. Some optimal matrix designs in stability studies. J. Biopharm. Stat. 1997, 7 (2), 205-213.
7. Helboe, P. New design for stability testing programs: Matrixing or factorial designs authorities' viewpoint on the predictive value of such studies. Drug Inf. J. 1992, 26, 629-634.
8. DeWoody, K.; Altan, S. Matrix designs in stability studies. Recent Advances in Experimental Designs and Related Topics; NOVA Science Publishers, Inc.: Hunting, NY, 2001; 87-94.
9. Fairweather, W.R. Design of stability studies: FDA statistical perspective. Paper Presented at Symposium, American Association of Pharmaceutical of Pharmaceutical Scientists Workshop on Stability Guidelines for Testing Pharmaceutical Products, Arlington, VA, 1994.
10. Nordbrock, E. Statistical comparison of stability drug designs. J. Biopharm. Stat. 1992, 2, 91-113.
11. Pong, A.; Raghavarao, D. Comparison of bracketing and matrixing designs for a two-year stability study. J. Biopharm. Stat. 2000, 10 (2), 217-228.
12. Pong, A.; Raghavarao, D. Shelf Life Estimation for Drug Products with Two Components, Proceedings of the Section of Biopharmaceutical Statistics; American Statistical Association, 2001.
13. Natarajan, J.; Altan, S.; Raghavarao, D. Expiration dating of pharmaceutical compounds in relation to analytical variation, degradation rate, and matrix designs. Drug Inf. J. 1997, 31, 589-595.
14. Sun, Y.; Chow, S.C.; Li, G.; Chen, K.W. Assessing distribution of estimated drug shelf lives in stability analysis. Biometrics 1999, 55, 896-899.
15. Shao, J.; Chow, S.C. Statistical inference in stability analysis. Biometrics 1994, 50, 753-763.