Application of in vitro release methods to assure product performance of semisolid dosage forms before and after certain post-approval changes

Dissolution Technologies

Volumn 5, Issue 3, 1998, Pages 5-11

  Shah, Vinod P ^a   Elkins, Jerome ^a   Schuirman, Donald ^a   Pelsnr, Francis ^a   Shrivastava, Surendra ^a   Decamp, Wilson ^a   Schwartz, Paul ^a   Williams, Roger ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL EQUIPMENT; ARTICLE; CONFIDENCE INTERVAL; DIFFUSION CELL SYSTEM; DRUG APPROVAL; DRUG DOSAGE FORM; DRUG RELEASE; FILTERS AND MEMBRANES; FOOD AND DRUG ADMINISTRATION; IN VITRO RELEASE TEST; IN VITRO STUDY; PRACTICE GUIDELINE; QUALITY CONTROL; SAMPLING; SEMISOLID DRUG DOSAGE FORM;

EID: 84862865277     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT050398P5     Document Type: Article

References (12)

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2. Workshop on: Assessment of Value and Applications of in vitro Testing of Topical Dermatologica! Drug' Products, sponsored by American Association of Pharmaceutical Scientists and FDA: September 1997.
3. Workshop report: Scale-Up of Liquid and Semisolid Disperse Systems. Van Buskirk, G.A., V. P. Shah, D. Adair et.al. Pharmaceutical Research, 11, 1216-1220, 1994.
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9. Zatz, J.L., “Drug Release from Semisolids: Effect of Membrane Permeability on Sensitivity to Product Parameters,” Pharmaceutical Research 2:787-789, 1995.
10. Zatz, J.L., and J. D. Segers, “Techniques for measuring in vitro release from semisolids.” Dissolution Technologies, 5, 3-17, 1998.
11. Conover, W.J., Practical Nonparametric Statistics (Second Edition), John Wiley & Sons, page 223ff, 1980.
12. Hollander, M. and D.A. Wolfe, Nonparametric Statistical Methods, John Wiley & Sons, page78ff, 1973.