《药物安全药理学研究技术指导原则》和《药物QT间期延长潜在作用非临床研究技术指导原则》与ICH S7A/S7B的对比研究及实施建议

Comparison and suggestion for implementation of “Safety pharmacology studies guideline for human pharmaceuticals” and “the non-clinical evaluation guideline of the potential for QT interval prolongation by human pharmaceuticals” with ICH S7A/S7B guidel

对比我国《药物安全药理学研究技术指导原则》和《药物QT间期延长潜在作用非临床研究技术指导原则》与ICH S7A/S7B相关指导原则的差别,为前者的修订和实施提供参考。以ICHS7A/S7B为基础,逐个条目对比我国相关两个指导原则的差别,并分析国内指导原则的修改方向及可实施性。我国的两个指导原则与ICHS7A/S7B的对比结果显示,我国和ICH在总体上对于非临床研究中对于药物安全药理学和QT间期延长潜在作用问题上的处理意见相同,在某些细节上,我国的两个指导原则描述的内容更为全面和具体。因此,国内指导原则可对ICHS7A/S7B有所借鉴,并依据国内实际情况加以修订和实施,从而提高指导原则对实际操作的指导意义。

The differences of ＂Safety pharmacology studies guideline for human pharmaceuticals＂ and ＂the non-clinical evaluation guideline of the potential for QT interval prolongation by human pharmaceuticals＂ with ICH S7 A/S7 B guidelines were compared, which provides a reference for amendment and implementation of the former. The differences between Chinese two guidelines and ICH S7 A/S7 B were described, and the revise orientation and applicable in China were analyzed. The contrasted results indicate that Chinese and ICH guidelines have the same opinions on researches of the safety pharmacology and QT interval prolongation in non-clinical studies, and the descriptions in certain parts of Chinese two guidelines are more comprehensive and specific. Therefore, according to ICH S7 A/S7 B, Chinese guidelines should be revised and operated based on domestic situation to enhance the guided significance for operation.