USP responses to comments on stimuli article, "Proposed change to acceptance criteria for dissolution performance verification testing"

Pharmacopeial Forum

Volumn 34, Issue 2, 2008, Pages 474-476

  Hauck, Walter W ^a   Cecil, Todd L ^a   Brown, William ^a   Abernethy, Darrell R ^a   Koch, William F ^a   Williams, Roger L ^a  

^a UNITED STATES PHARMACOPEIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

PREDNISONE; SALICYLIC ACID;

ARTICLE; CALIBRATION; DRUG DOSAGE FORM; DRUG MANUFACTURE; DRUG QUALITY; DRUG SOLUBILITY; PARTICLE SIZE; PHARMACY; QUALITY CONTROL; STANDARD; STANDARDIZATION; TABLET DISINTEGRATION; TABLET FORMULATION; TABLET HARDNESS;

EID: 44649191676     PISSN: 03634655     EISSN: 15421945     Source Type: Journal    
DOI: None     Document Type: Article

References (14)

1. Hauck WW, Manning RG, Cecil TL, Brown W, Williams RL. Proposed change to acceptance criteria for dissolution performance verification testing. Pharm Forum. 2007;33(3):574-579.
2. Deng G, Ashley AJ, Brown WE, et al. The USP performance verification test part 1: USP Lot P Prednisone Tablets - quality attributes ad experimental variables contributing to dissolution variance. Pharm Res. 2007; in press.
3. Glasgow M, Dressman S, Brown WE, et al. The USP performance verification test part II: collaborative study of USP's Lot P Prednisone Tablets. Pharm Res. 2007; in press.
4. Nithyanandan P, Deng G, Brown W, Manning R, Wahab S. Evaluation of the sensitivity of USP Prednisone Tablets to dissolved gas in the dissolution medium using USP Apparatus 2. Dissolution Technol. 2006;13(3)15-18
5. Eaton J, Deng G, Hauck WW, Brown W, Manning RG, Wahab S. Perturbation study of dissolution apparatus variables - a design of experiment approach. Dissolution Technol. 2007;14(2): 20-26.
6. Liddell MR, Deng G, Hauck WW, Brown WE, Wahab SZ, Manning RG. Evaluation of glass dissolution vessel dimensions and irregularities. Dissolution Technol. 2007;14(2):28-33.
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9. Reference Standards Expert Committee Subcommittee on Certified Reference Materials, Manning RG, Lane S, Dressman S, Hauck WW, Williams RL. The application of uncertainty to USP's compendial reference standards program: certified reference materials. Pharm Forum. 2007;33(6):1300-1310.
10. Marshall K, Foster TS, Carlin HS, Williams RL. Development of a compendial taxonomy and glossary for pharmaceutical dosage forms. Pharm Forum. 2003;29(5):1742-1752.
11. Shah VP, Ueda CT. USP advisory panel on the USP performance test for topical and transdermal dosage forms. Pharm Forum. 2006;32(5):1584-1585.
12. Shargel, L, Foster, TS. USP advisory panels on the USP performance test. Pharm Forum. 2005;31(6):1742-1744.
13. Burgess DJ, Clark BC, Hapson-Carlin MJ, Shah P. Critical quality and performance parameters for modified-release parenteral dosage forms. Pharm Forum. 2005;31(6):1745-1748.
14. Hauck WW, Shah VP, Shaw SW, Ueda CT. Reliability and reproducibility of vertical diffiision cells for determining release rates from semisolid dosage forms. Pharm Res. 2007;24(11):2018-2024.