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Sie suchen in allen Bereichen nach dem Autor Hoffelder T.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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Highly Variable Dissolution Profiles
Rubrik: Originale
(Treffer aus pharmind, Nr. 04, Seite 587 (2016))
Highly Variable Dissolution Profiles / Comparison of T2-Test for Equivalence and f2 Based Methods · Hoffelder T · Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein
Bootstrap Dissolution Profiles Multivariate Equivalence Similarity Factor f 2 T 2 -Test for Equivalence The FDA [ 1 ] states that for each postapproval change the manufacturer must prove that quality, safety and efficacy are not affected by the change. The question “ Is the drug product made after the change equivalent to the drug product before the change?” has to be answered. One of the crucial quality parameters is the dissolution profile of the product. Thus, the manufacturer has to demonstrate that the dissolution profile of the drug product before the change (reference group) is equivalent to the dissolution ...
