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精品资料网()25万份精华管理资料,2万多集管理视频讲座精品资料网()专业提供企管培训资料中药、天然药物临床研究资料综述撰写格式和要求技术指导原则(第二稿草稿)二OO五年三月1目录一.概述································································································································1二.撰写格式和要求··············································1(一)申请临床研究·········································································································11.主要内容···················································································································11.1命名依据··············································································································11.2立题目的和依据································································································11.3临床研究计划·····································································································21.3.1人体耐受性试验方案················································································21.3.2Ⅱ期临床试验方案·························································································22.分析与评价····························································································3(二)申请生产··················································································································31.主要内容···················································································································41.1Ⅰ期临床试验概要···························································································41.1.1人体耐受性试验概要···············································································41.1.2临床药理学试验概要···············································································41.2Ⅱ期临床试验概要·····························································································51.3Ⅲ期临床试验概要·····························································································52.分析与评价··························································································7三.参考文献·······················································································································8四.著者·······················································································································8附:《中药、天然药物临床研究资料综述格式和要求》技术指导原则起草说明····················································································································91一、概述本指导原则是根据《药品注册管理办法》的有关要求,结合我国中药、天然药物研发的实际情况而制订。本指导原则旨在通过对中药、天然药物临床研究资料综述的格式和内容等方面的要求,进一步规范申报资料,并加强药品注册申请人对新药研发过程及结果的分析和自我评价。本指导原则提供了不同注册类别可能涉及的内容,药物研究人员需按照《药品注册管理办法》中对不同注册申请类别的要求,结合中药、天然药物的不同特点及具体品种特点,合理取舍,确定各自所需要提供的资料和临床研究内容,把握重点,在此基础上,科学、客观、规范地撰写临床研究资料综述。要求文字简炼,逻辑合理,重点突出。本指导原则按照申请临床研究、申请生产两个阶段分别进行阐述。具体内容包括主要结果、分析与评价两部分。二、撰写格式和要求(一)申请临床研究本部分内容为支持进入临床研究的所有与临床有关的理论与试验研究资料的简要介绍。应注意围绕适应病症,对处方合理性、创新性及临床研究的科学性、可行性进行简明扼要的论述。1.主要内容1.1简述命名依据药品名称应符合《中药命名原则》及其它有关规定。1.2立题目的和依据2简述拟选择适应病症的病因、病机、治疗等研究现状及存在的主要问题;说明有关文献综述检索工具、查询范围(包括时间)。简述与国内外已上市同类品种比较,申请注册药物的特点和拟临床定位。简述处方来源,处方中君、臣、佐、使及各自功用(如非按照中医理论组方,可略),明确处方中是否含有毒性药材及十八反、十九畏等配伍禁忌;如有临床应用经验,还应简述原临床适应病症、用法、用量、疗程、疗效及效应特点、安全性情况。如为改变给药途径、改变剂型的品种,则只需简要说明拟选择新的剂型、给药途径的合理性依据,新标准与原标准的功能主治、日用生药量,并比较二者是否一致。1.3临床研究计划药物临床研究是一个有逻辑、有步骤的过程,早期研究结果应用于指导后期临床研究设计。本资料应明确临床试验各期的研究目的,概述Ⅰ期和Ⅱ期临床试验方案要点。1.3.1人体耐受性试验方案要点扼要概述:试验目的;受试者选择;主要试验方法;明确单次给药初始剂量、最高剂量、剂量梯度并简要说明确定依据;多次给药组组别设置、剂量、给药方法、给药时间;说明终止指标、观测指标、观测时点;简述预计可能出现的不良反应。1.3.2Ⅱ期临床试验方案要点根据试验目的和试验内容撰写,如为多个试验应分别撰写;如存在多个适应病症,也应分别撰写。扼要概述:试验目的;病例选择;诊断标准来源;中医辨证依据;临床试验设计类型和方法(例如,假设检验类别;对照药物及选择依据;进行剂3量研究应说明不同剂量设置依据);简述试验用药物(包括对照药物)的给药途径、剂量、给药次数、疗程和有关合并用药的规定;明确是否进行随访;明确主要疗效指标和次要疗效指标;安全性指标,可能出现的不良反应;简述疗效评价方法及依据。2.分析与评价以处方和适应病症为关注重点,从立题目的,立题依据,临床试验方案等方面对申请注册药物进行客观的综合评价。应特别关注与已上市用于相同适应病症的品种比较,本品的优点、特点及开发意义和价值。注意处方组成与拟选择适应病症病因、病机、治法是否相符合。所述结论应来源于文献资料和/或已有的研究结果,应具体、客观、具有逻辑性。关注临床试验方案的科学性,是否参考了药学、药效学、毒理学试验结果及先期临床研究结果,是否符合法规要求。(二)申请生产本部分内容为支持新药生产上市的所有临床资料的概要式总结。临床试验研究总结应作为重点内容。围绕有效性、安全性进行要点式阐述。临床试验一览表(见下页)试验编号试验目的试验方法(设盲水平,对照情况)观察周期完成例数(试验组/对照组)4试验一试验二试验三……1.主要内容1.1Ⅰ期临床试验概要1.1.1人体耐受性试验概要简述受试者选择标准。简述试验设计方法、试验例数。单次给药组:起始剂量、最大剂量、剂量梯度及确定依据;终止指标、观测指标、观测时点;给药后观察结果,出现的不良反应、异常检测结果及原因分析。多次给药组:剂量设置、给药方法、疗程及确定依据;终止指标、观测指标、观测时点;给药后观察结果,出现的不良反应、异常检测结果及原因分析。人体耐受性试验结论:①安全剂量;②未发生不良反应(包括异常检测结果)的剂量;③发生轻度不良反应(包括异常检测结果)的剂量;④发生中度、重度不良反应(包括异常检测结果)的剂量;⑤不良反应(包括异常检测结果)的性质,危害程度,发生时间,持续时间,有无前期征兆等;⑥推荐2期临床研究的剂量和理由。1.1.2临床药理学试验概要(1)人体生物材料研究:重点为通透性研究(如肠道吸收、血脑屏障通过情况)、蛋白结合情况、肝脏代谢情况、与代谢有关的药物相互作用情况等。5(2)人体药代动力学(PK)研究、药效学(PD)研究:总结不同受试人群、内在因素(IntrinsicFactors)和外在因素(ExtrinsicFactors)对PK和PD的影响,为不同目标适应症人群(如儿童、老年患者、肝肾功能不全患者)用药剂量及剂量调整、用药间隔选择提供依据。最后,根据对人体生物材料研究、人体药代动力学、药效学研究的总结与分析,提供出药代动力学研究的观点,为后续的临床研究提供支持。在分析过程中应考虑所有相关的数据,说明对结论的支持程度。1.2Ⅱ期临床试验概要Ⅱ期临床试验为探索性研究,不同目的的试验应分别叙述,试验设计内容可根据需要确定,撰写格式参考Ⅲ期临床试验。以Ⅱ期临床试验结果为依据,对有关疗效、安全性的重要结论进行简明扼要的说明。对本品特点进行初步总结和分析,其内容既不应该是结果的简单重复,也不应该引入新的结果,重点应对Ⅲ期临床试验设计提供依据。1.3Ⅲ期临床试验概要根据试验目的和试验内容撰写,如为多个试验应分开撰写,如存在多个适应病症,应分别撰写。1.3.1试验目的具体说明本项试验的受试因素、受试对象、研究效应,明确试验要回答的主要问题,明确药品在相关适应病症治疗中的定位。1.3.2病例选择诊断标准及来源;和/或中医辨证依据;疾病分型(或分期、分度、分级)标准及来源6纳入病例标准排除病例标准1.3.3试验方法简述临床试验总体设计类型和方法(例如,采用对照方法,应说明对照组选择依据;如进行剂量研究
本文标题:天然药物临床研究资料综述撰写技术指导原则
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