Setting dissolution specifications

Dissolution Technologies

Volumn 4, Issue 3, 1997, Pages 5-8

  Wojcik, Robert C ^a  

^a WYETH RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DISSOLUTION; DRUG FORMULATION; MATHEMATICAL MODEL; MONTE CARLO METHOD; NONPARAMETRIC TEST; PRACTICE GUIDELINE; PROBABILITY; SAMPLE SIZE;

EID: 84962082108     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT040397P12     Document Type: Article

References (8)

1. Subcommittee PI 13 (Pharmaceutics—Dissolution), “Revised Guidelines on Dissolution Requirements,” Pharmacopeial Forum, 6(6):610 (1980).
2. G. C. Davis, J. R. Murphy, D. A. Weisman, S. W. Anderson, and J. D. Hofer, “Rational Approaches to Specification Setting: An Opportunity for Harmonization,” Pharmaceutical Technology, 20(9): 110-118 (1996).
3. Natrelia, M., “Statistical Tolerance Limits,” Experimental Statistics, National Bureau of Standards Handbook 91, 1(3), pp. 2-13
4. T. Givand, “An Evaluation of the Dissolution Test Acceptance Plan for USP XX,” Pharmacopeial Forum, 6(2): 186-192 (1980).
5. Pharmacopeia I Previews, “Dissolution-Test Load Reduction Procedure for Pooled Samples of Faster Dissolving Immediate-release Dosage Forms,” Pharmacopeial Forum, 1995; 21(1):42.
6. R. C. Wojcik, A. Zimmermann, M. Utter, and A. Cundell, “An Evaluation of the Dissolution Test Acceptance Sampling Procedure lor Pooled Samples,” Pharmacopeial Forum, 21 (4): 1169-1175 (1995).
7. S. S. Shapiro and A. J. Gross, “Statistical Modeling Techniques”, “STATISTICS: textbooks and monographs, Volume 38, Marcel Dekker, Inc. New York, 1981 pp. 273-296.
8. Microsoft, Inc., Microsoft Excel, Version 5.0, Redmond, Washington.