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Highly Variable Dissolution Profiles
Comparison of T2-Test for Equivalence and f2 Based Methods
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1.Introduction 2.Materials and methods 3.Results 4.Discussion 5.Conclusion Anzeigen
Thomas Hoffelder · Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
Correspondence:
Thomas Hoffelder, Boehringer Ingelheim Pharma GmbH & Co. KG, Biostatistics & Data Sciences, Binger Str. 173, 55216 Ingelheim am Rhein (Germany),
e-mail: thomas.hoffelder@boehringer-ingelheim.com
Abstract
Equivalence assessment for highly variable dissolution profiles is a crucial topic in the Chemistry, Manufacturing and Control (CMC) context. This article compares T2-test for equivalence and methods based on the similarity factor f2 regarding practical and statistical properties. Both methods are put in context with the recommendations given in FDA and EMA guidelines. (...)