Literature DB >> 15796294

A multivariate test for similarity of two dissolution profiles.

H Saranadasa1, K Krishnamoorthy.   

Abstract

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 the methods are illustrated with real examples.

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Year:  2005        PMID: 15796294     DOI: 10.1081/bip-200049832

Source DB:  PubMed          Journal:  J Biopharm Stat        ISSN: 1054-3406            Impact factor:   1.051


  3 in total

Review 1.  The science of USP 1 and 2 dissolution: present challenges and future relevance.

Authors:  Vivian Gray; Gregg Kelly; Min Xia; Chris Butler; Saji Thomas; Stephen Mayock
Journal:  Pharm Res       Date:  2009-01-23       Impact factor: 4.200

2.  Dissolution comparisons using a Multivariate Statistical Distance (MSD) test and a comparison of various approaches for calculating the measurements of dissolution profile comparison.

Authors:  J-M Cardot; B Roudier; H Schütz
Journal:  AAPS J       Date:  2017-03-28       Impact factor: 4.009

3.  Development of a Flow-Through USP-4 Apparatus Drug Release Assay to Evaluate Doxorubicin Liposomes.

Authors:  Wenmin Yuan; Rui Kuai; Zhipeng Dai; Yue Yuan; Nan Zheng; Wenlei Jiang; Charles Noble; Mark Hayes; Francis C Szoka; Anna Schwendeman
Journal:  AAPS J       Date:  2016-08-02       Impact factor: 4.009

  3 in total

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