Estimation of the probability of passing the USP dissolution test

Journal of Biopharmaceutical Statistics

Volumn 17, Issue 3, 2007, Pages 407-413

  Wang, Hsiuying ^a  

^a INSTITUTE OF STATISTICAL SCIENCE   (Taiwan)

Author keywords

Dissolution test

Indexed keywords

ARTICLE; CALCULATION; DISSOLUTION; DRUG MANUFACTURE; DRUG STABILITY; PRIORITY JOURNAL; PROBABILITY; QUANTITATIVE STUDY; VARIANCE;

CHEMISTRY, PHARMACEUTICAL; COMPUTER SIMULATION; MODELS, STATISTICAL; PHARMACEUTICAL PREPARATIONS; PROBABILITY; QUALITY CONTROL; SOLUBILITY; TECHNOLOGY, PHARMACEUTICAL; UNITED STATES;

EID: 34247893782     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400701199536     Document Type: Article

References (5)

1. USP/NF (2000). The United States Pharmacopedia XXIII and the National Formulary XVIII. Rockville, MD: The United States Pharmacopedial Convention.
2. Bergum, J. S. (1990). Constructing acceptance limits for multiple stage tests. Drug Dev. Ind. Pharm. 16:2153-2166.
3. Chow, S. C., Liu, J. P. (1995). Statistical Design and Analysis in Pharmaceutical Science. New York: Marcel Dekker.
4. Chow, S. C., Shao, J. (2002). Statistics in Drug Research: Methodologies and Recent Developments. New York: Marcel Dekker.
5. Chow, S. C., Shao, J., Wang, H. (2002). Probability lower bounds for USP/NF tests. J. Biopharm. Stat. 1:79-92.