Use of matrix designs in stability studies: A simulation study

Drug Information Journal

Volumn 33, Issue 3, 1999, Pages 859-868

  DeWoody, Kimberly L ^a   Raghavarao, Damaraju ^b  

^a CENTOCOR INC   (United States)

^b TEMPLE UNIVERSITY   (United States)

Author keywords

Drug stability study; Expiration dating period; Matrix designs; Uniform matrix designs

Indexed keywords

ARTICLE; DRUG DEGRADATION; DRUG STABILITY; EXPIRATION DATE; PRIORITY JOURNAL; SHELF LIFE; SIMULATION;

EID: 0032788212     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159903300327     Document Type: Article

References (7)

1. Food and Drug Administration. Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics. Rockville, Maryland: Center for Drugs and Biologies, Office of Drug Research and Review; 1987.
2. Food and Drug Administration. Draft guidance for industry on stability testing of drug substances and drug products; availability. Fed Reg. 1998;63(109): 31224-31225.
3. 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(2):589-595.
4. Nordbrock E. Statistical comparison of stability study designs. J Biopharm Stat. 1992;2(1):91-113.
5. DeWoody K, Raghavarao D. Some optimal matrix designs in stability studies. J Biopharm Stat. 1997; 7(2):205-213.
6. Murphy JR. Uniform matrix stability study designs. J Biopharm Stat. 1996;6(4):477-494.
7. DeWoody K. Some optimal matrix designs in stability studies. PhD dissertation. Temple University, Ann Arbor, MI: UMI; 1999:9911000.