Rifampin Drug–Drug–Interaction Studies: Reflections on the Nitrosamine Impurities Issue
Rifampin Drug–Drug–Interaction Studies: Reflections on the Nitrosamine Impurities Issue
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利福平药物相互作用研究：对亚硝胺杂质问题的思考
DOI：
10.1002/cpt.2652
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发表时间：
2022
影响因子：
6.7
通讯作者：
S. Paglialunga
中科院分区：
文献类型：
--
作者：
A. V. van Haarst;Stephen Smith;Clare Garvin;Natacha Benrimoh;S. Paglialunga
新药的临床开发可能需要专门的药物相互作用（DDI）研究，例如评估细胞色素P450 3A诱导对试验药物药代动力学的影响。然而，由于在市售利福平制剂中发现N-亚硝胺杂质，已停止在DDI研究中应用利福平。该小型审查考虑了亚硝胺杂质的根本原因和影响，以及继续进行DDI的替代方案。
Clinical development of new drugs may require dedicated drug–drug interaction (DDI) studies, such as to evaluate the effect of cytochrome P450 3A induction on the pharmacokinetics of investigational drugs. However, as a result of N‐nitrosamine impurity findings in marketed rifampin formulations, the application of rifampin in DDI studies has been halted. This mini‐review considers the root cause and impact of the nitrosamine impurity as well as alternative options for the continued conduct of DDIs.
影响因子：
15.9
作者：
Grossman, Stuart A.;Olson, Jeffrey;Supko, Jeffrey G.
通讯作者：
Supko, Jeffrey G.