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

Bojňanská, Erika; Kalina, Michal; Pařízek, Ladislav; Bartoníčková, Eva; Opravil, Tomáš; Veselý, Michal; Pekař, Miloslav; Jampílek, Josef (Hindawi Publishing Corporation, 2014-09-15)
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 ...

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Author
Bartoníčková, Eva (1)
Bojňanská, Erika (1)
Jampílek, Josef (1)
Kalina, Michal (1)
Opravil, Tomáš (1)
Pařízek, Ladislav (1)
Pekař, Miloslav (1)
Veselý, Michal (1)
Subjectaktivní farmaceutické substance (1)Critical Quality Attributes; Active Pharmaceutical Ingredient; Dissolution testing (1)distribuce velikosti částic (1)
dozpustnost (1)
Kritické parametry kvality (1)
Particle size distribution (1)
Scanning electron microscopy (1)
skenovací elektronová mikroskopie (1)
Specific surface area (1)
specifický povrch (1)... View MoreDate Issued2014 (1)

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