Description of the upcoming change in data analysis for USP dissolution performance verification tests

Dissolution Technologies

Volumn 16, Issue 1, 2009, Pages 7-12

  Hauck, Walter W ^a   DeStefano, Anthony J ^a   Brown, William E ^a   Stippler, Erika ^a   Abernethy, Darrell R ^a   Williams, Roger L ^a   Foster, Thomas S ^b   Polli, James E ^c   Burgess, Diane J ^d   Bryan Crist, G ^e   Gonzalez, Mario A ^f   Gray, Vivian A ^g   Kraemer, Johannes ^h   Leeson, Lewis J ⁱ   Parr, Alan F ^j   Shargel, Leon ^h   Shefter, Eli ^h   Craig Simon, W ^k   Tran, Nhan L ^l   Ueda, Clarence T ^h  

^a UNITED STATES PHARMACOPEIA   (United States)

^b UNIVERSITY OF KENTUCKY MEDICAL CENTER   (United States)

^c UNIVERSITY OF MARYLAND   (United States)

^d UNIVERSITY OF CONNECTICUT   (United States)

^e Varian Inc   (United States)

^f P'Kinetics International Inc   (United States)

^g V A GRAY CONSULTING INC   (United States)

^h Phast ^*

ⁱ LJL Associates Inc

^j GLAXOSMITHKLINE   (United Kingdom)

^k HEALTH CANADA   (Canada)

^l Lachman Consultant Services Inc   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CHLORPHENIRAMINE MALEATE; PREDNISONE; SALICYLIC ACID;

ARTICLE; DATA ANALYSIS; DRUG SOLUBILITY; LABORATORY; REFERENCE VALUE; TABLET FORMULATION;

EID: 69349098316     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT160109P7     Document Type: Article

References (10)

1. Deng, G.; Ashley, A. J.; Brown, W. E., et al. The USP performance verification test, part I: quality attributes and experimental variables contributing to dissolution variance. Pharm. Res. 2008, 25 (5), 1100-1109.
2. Glasgow, M.; Dressman, S.; Brown, W. E., et al. The USP performance verification test, part II: collaborative study of USP's Lot P Prednisone Tablets. Pharm Res. 2008, 25 (5), 1110-1115.
3. Hauck, W. W.; Manning, R. G.; Cecil, T. L.; Brown, W. E.; Williams, R. L. Proposed change to acceptance criteria for dissolution performance verification testing. Pharm. Forum 2007, 33 (3), 574-579.
4. Hauck, W. W.; Cecil, T. L.; Brown, W. E.; Abernethy, D. R.;Koch, W. F.; Williams, R. L. USP responses to comments on Stimuli article, "Proposed change to acceptance criteria for dissolution performance verification testing." Pharm. Forum 2008, 34 (2), 474-476.
5. Dissolution <711>. In United States Pharmacopeia and National Formulary USP 31-NF 26; The United States Pharmacopeial Convention, Inc.: Rockville, MD, 2008; pp 267-274.
6. Uniformity of Dosage Units <905>. In United States Pharmacopeia and National Formulary USP 31-NF 26; The United States Pharmacopeial Convention, Inc.: Rockville, MD, 2008; pp 363-369.
7. ISO. Accuracy (Trueness and Precision) of Measurement Methods and Results-Part 6: Use in Practice of Accuracy Values. ISO 5725-6:1994; Geneva, Switzerland, 1994.
8. ISO. Guidance for the use of repeatability, reproducibility, and trueness estimates in measurement uncertainty estimation. ISO/TS 21748:2004; Geneva, Switzerland, 2004.
9. General Notices, Significant Figures and Tolerances. In United States Pharmacopeia and National Formulary USP 31-NF 26; The United States Pharmacopeial Convention, Inc.: Rockville, MD, 2008; p 4.
10. Toolkit. Dissolution Procedure: Mechanical Calibration and Performance Verification Test. http://www.usp. org/USPNF/compendialTools.html (accessed Jan 13, 2009).