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贝叶斯方法在肿瘤新药早期临床研发中的发展与应用
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作者 黄慧瑶 刘梅若 +5 位作者 李喜艳 孟鑫雨 崔丹丹 冷烨 唐玉 李宁 《中国肺癌杂志》 CAS CSCD 北大核心 2022年第10期730-734,共5页
贝叶斯学派是通过综合未知参数的先验信息与样本信息,依据贝叶斯定理,求出后验分布,根据后验分布推断未知参数的统计方法。相比频率派,贝叶斯学派更加灵活、高效。肿瘤新药是全球研发的热点,但同时也存在高失败率的风险。在肿瘤新药早... 贝叶斯学派是通过综合未知参数的先验信息与样本信息,依据贝叶斯定理,求出后验分布,根据后验分布推断未知参数的统计方法。相比频率派,贝叶斯学派更加灵活、高效。肿瘤新药是全球研发的热点,但同时也存在高失败率的风险。在肿瘤新药早期研发中,高效寻找最佳剂量、优势人群、估计疗效和成功率是医药企业和研究者的共同需求。近年来,肿瘤新药研发呈现化学药物生物制品转变、单药治疗向联合治疗转变、传统设计向创新设计转变等新趋势;伴随出现的各种挑战,包括无法找到最高耐受剂量、延迟毒性、延迟反应、剂量疗效关系变化、剂量组合众多等。基于贝叶斯方法,恰当借用先验信息,能有效帮助企业在肿瘤早期研发中,实现从传统研发模式(高投入、长周期、低效率)向现代研发模式(低投入、短周期、高效率)的转变。研究还进行了贝叶斯方法在肿瘤新药早期研发的进展阐述,与频率派的理念、应用场景的比较分析,可为医药研发的所有从业人员提供宏观、系统的参考。 展开更多
关键词 早期试验 贝叶斯 统计设计 肿瘤
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Determination of cefcapene acid by LC-MS and their application to a pharmacokinetic study in healthy Chinese volunteers 被引量:1
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作者 Hong-Fei Duan Li Ding +4 位作者 Xiao-Bing Li Lin-Lin Hu Ai-Dong Wen ye leng Zhen Liu 《Journal of Pharmaceutical Analysis》 SCIE CAS 2013年第2期84-92,共9页
Simple,rapid and specific liquid chromatography-mass spectrometry(LC-MS) methods have been developed and validated for the quantification of cefcapene acid in human plasma and urine.Plasma samples were simply pretre... Simple,rapid and specific liquid chromatography-mass spectrometry(LC-MS) methods have been developed and validated for the quantification of cefcapene acid in human plasma and urine.Plasma samples were simply pretreated with methanol for deproteinization.Urine samples were briefly diluted with methanol-water(50:50,v/v),and centrifuged to remove large particles.Chromatographic separation was performed on a Hedera ODS-2 column.For the plasma assay,the isocratic mobile phase consisted of 35% solvent A(Methanol) and 65% solvent B(10 mM ammonium acetate buffer solution containing 0.2% folic acid) with a flow rate of 0.3 mL/min.For the urine assay,the isocratic mobile phase consisted of 30% solvent A(Methanol) and 70% solvent B(10 mM ammonium acetate buffer solution containing 0.2% folic acid) with a flow rate of 0.3 mL/min.The assays were linear over the concentration ranges of 0.03-5 μg/mL in plasma and 0.1-400 μg/mL in urine,and were successfully applied to a pharmacokinetic study after single and multiple oral administrations of cefcapene pivoxil hydrochloride tablets in healthy Chinese volunteers. 展开更多
关键词 Cefcapene acid Cefcapene pivoxil LC-MS Human plasma Urine Pharmacokinetics
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