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Multivariate equivalence tests for use in pharmaceutical development.
Hoffelder, Thomas; Gössl, Rüdiger; Wellek, Stefan.
Affiliation
  • Hoffelder T; a Boehringer Ingelheim GmbH & Co. KG , Ingelheim , Germany.
J Biopharm Stat ; 25(3): 417-37, 2015.
Article in En | MEDLINE | ID: mdl-24896319
Statistical equivalence analyses are well-established parts of many studies in the biomedical sciences. Also in pharmaceutical development and manufacturing equivalence testing methods are required in order to statistically establish similarities between machines, process components, or complete processes. This article presents a choice of multivariate equivalence testing procedures for normally distributed data as generalizations of existing univariate methods. In all derived methods, variability is interpreted as nuisance parameter. The use of the proposed methods in pharmaceutical development is demonstrated with a comparative analysis of dissolution profiles.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Pharmaceutical Preparations / Data Interpretation, Statistical / Drug Industry Language: En Journal: J Biopharm Stat Journal subject: FARMACOLOGIA Year: 2015 Document type: Article Affiliation country: Alemania Country of publication: Reino Unido

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Research Design / Pharmaceutical Preparations / Data Interpretation, Statistical / Drug Industry Language: En Journal: J Biopharm Stat Journal subject: FARMACOLOGIA Year: 2015 Document type: Article Affiliation country: Alemania Country of publication: Reino Unido