Determination of Critical Parameters of Drug Substance Influencing Dissolution: A Case Study

The purpose of this study was to specify critical parameters (physicochemical characteristics) of drug substance that can affect dissolution profile/dissolution rate of the final drug product manufactured by validated procedure from various batches of the same drug substance received from different...

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Bibliographic Details
Main Authors: Erika Bojnanska, Michal Kalina, Ladislav Parizek, Eva Bartonickova, Tomas Opravil, Michal Vesely, Miloslav Pekar, Josef Jampilek
Format: Article
Language:English
Published: Hindawi Limited 2014-01-01
Series:BioMed Research International
Online Access:http://dx.doi.org/10.1155/2014/929248