A matrixed approach to long-term stability testing of pharmaceutical products

Journal of Pharmaceutical Sciences

Volumn 85, Issue 2, 1996, Pages 240-245

  Golden, Michael H ^a   Cooper, David C ^a   Riebe, Michael T ^a   Carswell, Kimberly E ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

ARTICLE; DRUG EFFICACY; DRUG STABILITY; DRUG STORAGE; DRUG SYNTHESIS;

EID: 0030062751     PISSN: 00223549     EISSN: None     Source Type: Journal    
DOI: 10.1021/js950034i     Document Type: Article

References (6)

1. Guideline for Submitting Documentation for the Stability of Human Drugs and Biologics; Center for Drugs and Biologies, Food and Drug Administration, Department of Health and Human Services: Washington, DC, February 1987.
2. Stability Testing of New Drug Substances and Products. International Conference on Harmonization Tripartite Guideline, October 1993.
3. Box, G. E. P.; Hunter, W. G.; Hunter J. S. Statistics for Experimenters; John Wiley and Sons: New York, 1978; Chapters 10-13.
4. Nordbrock, E. J. Biopharm. Statist. 1992, 2(1), 91-113.
5. Snee, R. D. J. Quality Technol. 1985 (17), 222-236.
6. SAS Institute Inc., SAS/QC Software: Reference, Version 6, First Edition, Cary, NC.