On the assessment of similarity for dissolution profiles of two drug products.
Publication
, Journal Article
Chow, S-C; Shao, J
Published in: J Biopharm Stat
August 2002
The assessment of similarity between dissolution profiles of two drug products is considered. After reviewing some existing approaches, we propose a statistical method of assessing local and global similarities based on a time series model for the ratio of the dissolution results from two drug products and a polynominal model for the mean of the ratio. An example is presented for illustration.
Duke Scholars
Published In
J Biopharm Stat
DOI
ISSN
1054-3406
Publication Date
August 2002
Volume
12
Issue
3
Start / End Page
311 / 321
Location
England
Related Subject Headings
- Statistics & Probability
- Solubility
- Pharmaceutical Preparations
- Models, Statistical
- Kinetics
- Algorithms
- 4905 Statistics
- 3214 Pharmacology and pharmaceutical sciences
- 1115 Pharmacology and Pharmaceutical Sciences
Citation
APA
Chicago
ICMJE
MLA
NLM
Chow, S.-C., & Shao, J. (2002). On the assessment of similarity for dissolution profiles of two drug products. J Biopharm Stat, 12(3), 311–321. https://doi.org/10.1081/bip-120014561
Chow, Shein-Chung, and Jun Shao. “On the assessment of similarity for dissolution profiles of two drug products.” J Biopharm Stat 12, no. 3 (August 2002): 311–21. https://doi.org/10.1081/bip-120014561.
Chow S-C, Shao J. On the assessment of similarity for dissolution profiles of two drug products. J Biopharm Stat. 2002 Aug;12(3):311–21.
Chow, Shein-Chung, and Jun Shao. “On the assessment of similarity for dissolution profiles of two drug products.” J Biopharm Stat, vol. 12, no. 3, Aug. 2002, pp. 311–21. Pubmed, doi:10.1081/bip-120014561.
Chow S-C, Shao J. On the assessment of similarity for dissolution profiles of two drug products. J Biopharm Stat. 2002 Aug;12(3):311–321.
Published In
J Biopharm Stat
DOI
ISSN
1054-3406
Publication Date
August 2002
Volume
12
Issue
3
Start / End Page
311 / 321
Location
England
Related Subject Headings
- Statistics & Probability
- Solubility
- Pharmaceutical Preparations
- Models, Statistical
- Kinetics
- Algorithms
- 4905 Statistics
- 3214 Pharmacology and pharmaceutical sciences
- 1115 Pharmacology and Pharmaceutical Sciences