Research advances on drug impurity control and safety evaluation
Author(s): WANG Weijian, LIU Fei, NIU Chong, XIE Jizhen, ZHU Qingfen, HU Defu
Pages: 657-662
Year: 2016 Issue: 11
Journal: Qilu Pharmaceutical Affairs
Keyword: Impurity profile; Toxicology evaluation; Reference substance;
Abstract: As a key factor affecting the safety and effectiveness of drugs,impurity has always been the focus of drug quality research and safety evaluation.This paper focused on the two aspects of drug impurity control and safety evaluation, and summarized the research status of impurity profile,impurity toxicology evaluation,impurity reference substance prepara-tion and so on.
Pages: 657-662
Year: 2016 Issue: 11
Journal: Qilu Pharmaceutical Affairs
Keyword: Impurity profile; Toxicology evaluation; Reference substance;
Abstract: As a key factor affecting the safety and effectiveness of drugs,impurity has always been the focus of drug quality research and safety evaluation.This paper focused on the two aspects of drug impurity control and safety evaluation, and summarized the research status of impurity profile,impurity toxicology evaluation,impurity reference substance prepara-tion and so on.
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