信息技术在新药研究监管中的应用

对新药临床研究中应用信息技术（Information Technology,IT)的重要性及我国在新药研究与监管中存在的问题进行了深入分析，介绍了国外运用IT进行新药研究监管的情况和发展趋势，提出我国在新药研究监管中运用IT的可行性和必要性及注意的问题。     

中药新药用中药材质量标准的引用及相关问题探讨

目的：分析中药新药用中药材标准引用的相关问题,为准确引用提供参考。方法：对我国中药材标准管理历史、现状进行梳理,分析中药新药研究用中药材标准引用中存在的问题,并提出建议。结果与结论：针对中药材标准基原或药用部位不统一、标准可控性较低等问题,提出中药新药用中药材标准引用的基本原则及相关建议,为中药新药研究、评价、监管提供参考。     

新药生物统计的若干问题

根据新药临床研究指导原则，结合新药申报资料及审评体会，对新药研究的设计和统计中若干问题进行了论述。在临床前药理研究中讨论了动物剂量估算，剂量对应和复方研究问题。在临床研究中介绍了10年临床研究设计方式，讨论了等效性检验，非劣性检验，多中心资料，跨年度资料等问题，在统计分析方面列出了国内外新药研究常用的统计方法，讨论了计数资料和计量资料统计分析中应注意的问题。     

中药新药研发的问题与新模式

本文对中药研发中存在的问题进行探讨,系统介绍了我国中药研发的现状和主要存在的问题,并认为中药新药的研发,必须以传统的中医药理论为基础,注重临床试验疗效在新药研究中的地位并利用现代科学技术,建立中药新药研发的新模式。     

新药研究的国际标准化学术报告会在沪举行

中国药学会上海分会和上海医科大学药学院于1999年7月6日在市科协联合召开新药研究的国际标准化学术报告会,由美国FDA的赵洪博士主讲。据她介绍,新药研究的国际标准化问题,是全世界关注的问题。新药研究的标准全世界统一了,各国上市的新药就可彼此认可,这样就可以节省时间、节省费用。 过去FDA审批一个新药,要花很多时间,审批周期很长。自1992年开始,FDA审批新药实行收费制。新药研究公司可通过FDA召开一系列围绕新药研究     

全军新药研究的现状,趋势及对策

本文着重论述了近几年来全军新药研究的现状、趋势，新药研究报批中存在的问题及其对策以及新药研究、开发、转化为生产力的六个环节。     

新药研制中常见问题浅析

自1985年我国实施《新药审批办法》以来,我国的新药研究取得了很大的成绩,为防病治病作出了重大贡献。我省新药研制在全国处于领先地位,每年批准的新药占全国批准新药总数的10％以上。十多年来新药研制的技术要求已逐步规范化,但由于各研制者对新药研究技术要求掌握程度的差别,及申报经验等方面的原因,在新药研制过程中出现各种问题,造成报批的失败或延误。本文通过对本单位已批准的40份新药证书和10多个新药在研制过程中出现的常易发生的问题作一简要的分析,以供新药研制者参考。 对本单位已取得的新药证书进行统计表明,从研制立项开始到获得新药证书,二类西药、三类西药和四类西药的平均研制时间分别为5.5(3.5～7)、     

中药有效部位新药研发中关键问题分析

中药有效部位新药的研究开发中有许多问题有待于广泛、深入、全面的研究。文中从有效部位的确立、有效部位的制备、有效部位的质量研究3个方面着手,对中药有效部位新药研究开发过程中存在的一些主要问题进行了分析,并提出了解决办法。     

通过市场调研开拓中药新药研究新思路

作者对数家大医院和医药公司的常用中成药市场进行调查研究，发现目前中药新药研究中存在一些问题，并提出解决问题的新思路。指出中药新药研究和开发的突破口在于加强防治常见病、多发病中药新药的研制和开发，协调平衡发展，避免畸形发展；加强现代新制剂、新剂型的研究，使传统制剂与现代新制剂协调平衡发展，充分运用现代新技术、新工艺、新设备研制中药新药，提高中药新药研制的水平和档次；加强中药一、二类新药的研制．加强保健制剂的研制、生产、营销管理。     

中药新工节研究的特点

从新药研究和评价的角度,结合中药新药注册中的注意事项,对中药新药工艺研究的探索性、阶段性、针对性、关联性、可行性进行了讨论,并对中药新药工艺研究中的部分常见问题进行了分析,以期为中药新药的研发提供借鉴。     

The role of the suspicious renal pharmacist in identifying unusual adverse drug reactions—why this is not a small problem

Renal patients have a high incidence of adverse drug reactions due to both pharmacokinetic and pharmacodynamic changes and detecting these adverse drug reactions relies heavily on having a high index of suspicion—which seems to be invoked through experience, whether our own or that of our colleagues. Pharmacists must be vigilant about adverse drug reactions and it is vital that pharmacists continue to teach their colleagues about their experiences identifying less common adverse drug reactions and adverse drug reactions with unusual presentations in addition to simply reporting these adverse drug reactions.     

我院开展临床药师制工作的体会

多年来,我院认真实践卫生部的《医疗机构药事管理暂行规定》关于建立临床药师制的要求,从临床药师制工作的目标;临床药师制运行管理;临床药师工作要求;临床药师工作的规范化管理;临床药师工作的考核评价等方面开展临床药学工作,取得一定的成绩。现将我们的经验和体会加以介绍,旨在为广大同仁提供借鉴。     

我们是如何做好基层药品监督检验工作的

基层药品检验所如何做好药品监督检验工作,我们通过四年来的探索,摸索到了一些经验,介绍给同行们,以供参考。     

Glucose testing in patients receiving antipsychotic pharmacotherapy - author reply

We welcome the comments on our survey from Dr. Strouss and her colleagues. As they point out, our survey relied exclusively on physician self-reports, where the rate of reported plasma glucose testing was far higher than in their medical claims study. Self-report is likely a contributor to this difference.We appreciate that they noted we made a similar remark in considerations of limitations of our study.     

A new season of Chinese cardiovascular pharmacology research

In this issue of Acta Pharmacologica Sinica, we are proud to present to our readers and colleagues a series of review articles from several Chinese-American university laboratories in USA. These reviews are a collection of the proceedings from the 8th Chinese Cardiovascular Pharmacology Conference held on July 23-26, 2004 in Urumchi,     

药物致病病例编码总结

国际疾病分类ICD-10是一门具有一定难度和复杂性的学科.世界卫生组织（WHO）并未给予损伤中毒类疾病详尽的ICD-10编码指导,编码错误率普遍偏高.本文就我院近年遇到的药物致病病例编码进行总结分析,与同行们共同探讨其编码的准确性,以求编码标准化、规范化.     

Collegial ethics: what, why and how

Collegial ethics (CE) proposes that we support our colleagues whenever possible. It is more of a focus on the feelings of others rather than on our own. In spite of the importance of collegial interactions, CE is not usually taught. Courses in CE need to be developed, and collegial skills need to be identified, taught and practiced. Such skills would include: use of the golden rule, supportive communication, conflict resolution, and even the development of greater courage in our actions.     

Defensive efficacy interim design: Dynamic benefit/risk ratio view using probability of success

Traditional efficacy interim design is based on alpha spending which does not have intuitive interpretation and hence is difficult to communicate with non-statistician colleagues. The alpha-spending approach is based on efficacy alone and hence does not have the flexibility to incorporate newly emerged safety signal. Newly emerged safety signal may nullify the originally set efficacy boundary. In contrast, the probability of success (POS) concept has intuitive interpretation and hence can facilitate our communication with non-statistician colleagues and help to obtain health authority (HA) buying. The success criteria of POS are not restricted to statistical significance. Hence, POS has the capability to incorporate both efficacy and safety information. We propose to use POS and its credible interval to design efficacy interim. In the proposed method, the efficacy boundary is adjustable to offset newly emerged safety signal.     

Clinical pharmacology — Training and career

Summary As young physicians, attending and participating in various postgraduate clinical pharmacology training programmes, it is our experience that many of our clinical colleagues are not informed about (i) the definition or functions of a clinical pharmacologist, (ii) postgraduate education opportunities, or (iii) career prospects in this field. By reviewing the training and career opportunities in a country in which the speciality is well-developed (Great Britain) it may be possible partly to answer these points.     

国际药理学联合会(IUPHAR)贺信（英文）

<正>Better Medicines through Global Education and Research October 12,2015Dear Professor Du:On behalf of the International Union of Basic and Clinical Pharmacology(IUPHAR)we wish to extend our best wishes and congratulations to you and your colleagues as you celebrate the 30th anni-versary of the founding of the Chinese Pharmacological Society(CNPHARS).Over the past three