PMID: 8987074Dec 1, 1996Paper

In-vitro dissolution profile comparison: statistics and analysis, model dependent approach

Pharmaceutical Research
P M SatheV P Shah

Abstract

To develop and propose a "model dependent' approach for the in-vitro dissolution profiles comparison. Diltiazem hydrochloride tablet dissolution profiles were compared using a statistical approach based on a mathematical model. A similarity region (SR) was defined based on the intra- and inter-lot parameter variances of the final production size standard lots. Statistical distances between the test and reference lot parameter means were computed and normalized. A 90% confidence region (CR) was developed around the statistical distance. The confidence region was compared with the similarity region to assess the similarity or dis-similarity of the test and reference (REF) lot dissolution profiles. Two test lots, one with a "minor' modification (mm) the other with a "major' modification (MM), were evaluated. "Weibull' was selected as the "model' function. A comparison of the confidence regions around the statistical distance of "mm-REF' and "MM-REF' with the similarity region, suggested that the dissolution profiles of the "minor' modification lot were similar and that of "major' modification lot were dis-similar to the reference lot. A "model dependent' approach was shown to be useful for the inter-lot in-vitro dissolution profil...Continue Reading

Citations

Feb 16, 2010·Pharmaceutical Development and Technology·Haibing HeXing Tang
Oct 31, 2014·Journal of Biopharmaceutical Statistics·Steven NovickStan Altan
Jul 4, 2020·Drug Development and Industrial Pharmacy·Ivana Cotabarren, Loreana Gallo
Aug 9, 2003·Drug Development and Industrial Pharmacy·Marcela Hurtado y de la PeñaAlma Rosa Cortés Arroyo
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Jan 24, 2009·Pharmaceutical Research·Vivian GrayStephen Mayock
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