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
在药物发现研究的临床前和临床阶段,应用质量源于设计(QbD)方法开发色谱分析方法,以测定物质的完整杂质谱。
期刊:International Journal of Molecular Sciences
影响因子:4.9
doi:10.3390/ijms231810720
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