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Implementation of QbD Approach to the Development of Chromatographic Methods for the Determination of Complete Impurity Profile of Substance on the Preclinical and Clinical Step of Drug Discovery Studies

The purpose of this work was to demonstrate the use of the AQbD with the DOE approach to the methodical step-by-step development of a UHPLC method for the quantitative determination of the impurity profile of new CPL409116 substance (JAK/ROCK inhibitor) on the preclinical and clinical step of drug d...

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Detalles Bibliográficos
Autores principales:	Gurba-Bryśkiewicz, Lidia, Dawid, Urszula, Smuga, Damian A., Maruszak, Wioleta, Delis, Monika, Szymczak, Krzysztof, Stypik, Bartosz, Moroz, Aleksandra, Błocka, Aleksandra, Mroczkiewicz, Michał, Dubiel, Krzysztof, Wieczorek, Maciej
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2022
Materias:	Article
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9505031/ https://www.ncbi.nlm.nih.gov/pubmed/36142622 http://dx.doi.org/10.3390/ijms231810720

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