抗结核药物固定剂量复方制剂开发与评价的基本考虑
被引量:2
Consideration development and evaluation of fix-dose combination compound for anti-tuberculosis drugs
摘要
结合审评实践中发现的问题,初步探讨开发与评价抗结核药物复方制剂临床研究应考虑的问题。
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2007年第3期236-238,共3页
The Chinese Journal of Clinical Pharmacology
参考文献6
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同被引文献23
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1赵梅桂,赵安贵,龙卫军,林仕平,钟云辉,潘海宏,文善适.肺结核病人对抗结核FDC制剂治疗可接受性的研究[J].中国热带医学,2006,6(7):1154-1156. 被引量:8
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2徐帆,尚北城,冯恩富,李成艳,刘文英,徐贵丽.利福平异烟肼片在健康志愿者体内生物等效性研究[J].中国药师,2006,9(12):1096-1099. 被引量:2
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二级引证文献4
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1张琪,方虹霞,秦丹,洪治,郑金琪,杜勇.太赫兹时域光谱技术定性定量分析抗结核药物中的吡嗪酰胺和异烟肼[J].药物分析杂志,2016,36(6):1082-1088. 被引量:5
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2张立光.抗结核药固定剂量复合剂分析方法研究进展[J].当代化工,2017,46(2):305-307.
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3武新丽,韦双双,裴业春,赵景锋,王大勇.反相高效液相色谱法对小鼠血清中基因重组人促肾上腺皮质激素前体及其代谢物的测定[J].热带生物学报,2019,10(1):83-88.
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4王家祺,陈昆南,陈红英,周小琴,陈禧翎,卢瑞芯,王涌杰.HPLC自身校正因子法测定吡嗪酰胺片有关物质[J].广东化工,2023,50(18):172-174.
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1李南.营养保健品的开发与评价[J].上海水产大学学报,1996,5(4):252-257.
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2许伟彬,傅丽红,刘文丽,李鸿飞.医院药学计算机管理系统开发与评价[J].中国医院药学杂志,1998,18(9):422-423. 被引量:3
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3熊燃,赵明.抗结核药物固定剂量复方制剂概况及其申报中常见问题分析[J].中国临床药理学杂志,2007,23(6):471-473.
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4孙轶康,阮秀芳.我国药物临床试验实施中的问题及监管对策[J].中国药房,2010,21(25):2317-2319. 被引量:5