A MULTIVARIATE TEST FOR SIMILARITY OF TWO DISSOLUTION PROFILES
نویسندگان
چکیده
منابع مشابه
A multivariate test for similarity of two dissolution profiles.
A multivariate test of size a for assessing the similarity of two dissolution profiles is proposed. The inferential procedure is developed by using the approach for the common mean problem in a multivariate setup due to Halperin (1961). The performance of the proposed method is compared with Intersection Union Test as well as f2 criterion recommended by the FDA through a simulation study. All t...
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A multivariate test of size α for assessing the similarity of two dissolution profiles is proposed. The inferential procedure is developed using the approach for the common mean problem in a multivariate setup due to Halperin (15). The performance of the proposed method is compared with Intersection Union Test as well as criterion recommended by the FDA through a simulation study. All the metho...
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In vitro dissolution has been recognized as an important element in drug development to assure the quality of drug products. It determines the rate and extent of the drug release and could be used as a surrogate for bioequivalence (BE) trials under certain conditions. Although methods for assessing the similarity of dissolution profiles between two drug products are available in the literature,...
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ژورنال
عنوان ژورنال: Journal of Biopharmaceutical Statistics
سال: 2005
ISSN: 1054-3406,1520-5711
DOI: 10.1081/bip-200049832