Assessing distributions of estimated drug shelf lives in stability analysis.
Publication
, Journal Article
Sun, Y; Chow, SC; Li, G; Chen, KW
Published in: Biometrics
September 1999
A stability study is usually conducted to ensure that a drug product can meet the approved specifications prior to its expiration dating period (shelf life). Several approaches for determination of drug shelf life assuming random batches have been proposed. In this paper, we examine sampling distributions of the estimated shelf lives proposed by Shao and Chow (1994, Biometrics 50, 753-763). An application to some stability data from the pharmaceutical industry is presented.
Duke Scholars
Published In
Biometrics
DOI
ISSN
0006-341X
Publication Date
September 1999
Volume
55
Issue
3
Start / End Page
896 / 899
Location
England
Related Subject Headings
- Time Factors
- Statistics & Probability
- Models, Statistical
- Drug Stability
- Drug Industry
- Biometry
- 4905 Statistics
- 0199 Other Mathematical Sciences
- 0104 Statistics
Citation
APA
Chicago
ICMJE
MLA
NLM
Sun, Y., Chow, S. C., Li, G., & Chen, K. W. (1999). Assessing distributions of estimated drug shelf lives in stability analysis. Biometrics, 55(3), 896–899. https://doi.org/10.1111/j.0006-341x.1999.00896.x
Sun, Y., S. C. Chow, G. Li, and K. W. Chen. “Assessing distributions of estimated drug shelf lives in stability analysis.” Biometrics 55, no. 3 (September 1999): 896–99. https://doi.org/10.1111/j.0006-341x.1999.00896.x.
Sun Y, Chow SC, Li G, Chen KW. Assessing distributions of estimated drug shelf lives in stability analysis. Biometrics. 1999 Sep;55(3):896–9.
Sun, Y., et al. “Assessing distributions of estimated drug shelf lives in stability analysis.” Biometrics, vol. 55, no. 3, Sept. 1999, pp. 896–99. Pubmed, doi:10.1111/j.0006-341x.1999.00896.x.
Sun Y, Chow SC, Li G, Chen KW. Assessing distributions of estimated drug shelf lives in stability analysis. Biometrics. 1999 Sep;55(3):896–899.
Published In
Biometrics
DOI
ISSN
0006-341X
Publication Date
September 1999
Volume
55
Issue
3
Start / End Page
896 / 899
Location
England
Related Subject Headings
- Time Factors
- Statistics & Probability
- Models, Statistical
- Drug Stability
- Drug Industry
- Biometry
- 4905 Statistics
- 0199 Other Mathematical Sciences
- 0104 Statistics