Pharmacovigilance(药物警戒)E3ClinicalStudyReports(临床研究报告)E4Dose-ResponseStudies(量-效关系研究)E5EthnicFactors(种族因素)E6GoodClinicalPractice(药物临床研究质量管理规范)E7ClinicalTrialsinGeriatricPopulation(老年人群的临床试验)E8GeneralConsiderationsforClinicalTrials(临床试验的一般考虑)E9StatisticalPrinciplesfor...
EfficacyGuidelines 有效性 ClinicalSafetyforDrugsusedinLong-TermTreatment(长期用药的临 E1 床安全性) E2Pharmacovigilance(药物警戒) E3ClinicalStudyReports(临床研究报告) E4Dose-ResponseStudies(量-效关系研究) E5EthnicFactors(种族因素) E6GoodClinicalPractice(药物临床研究质量管理规范) E7ClinicalTrialsinGeriatricPop...
pharmacovigilance and by agencies regulating these industries Although there are some examples of the use of quality risk management in the pharmaceutical industry today they are limited and do not represent the full contributions that risk management has to offer In addition the importance of quality ...
some available suggestions from the foreign relevant guidelines Key words: risk management; pharmacovigilance; safety 新药上市之初,其安全性信息相对局限,这主要由于临床研究的 样本量有限,及年龄、性别、族群以及对合并疾病、伴随用药的限制, 使得入组
E2A - E2F Pharmacovigilance/药物警戒性 E2A: 临床安全性数据管理:快速报告的定义和标准 上市前、后的临床安全性报告,从概念 和实践上来说是相互依存的;而由于产品的阶段不同(研究 或上市阶段),在监管机构和企业内部,临床安全性的责任可 能归属于不同的部门 ...
ICH Guidelines 王震 20150201 ICH Guidelines 说明 ICH的论题主要分为四类,因此ICH根据论题的类别不同而进行相应的编 码分类: 1. Q类论题:Q代表QUALITY,指那些与化工和医药,质量保证方面
E1: The extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-term Treatment of Non-life-threatening ConditionsE1:人群暴露程度:评估非危及生命性疾病长期治疗药物的临床安全性阶段51994.10.27有 2E2A - E2F Pharmacovigilance/药物警戒性 ...
for Anticancer Pharmaceuticals〔抗癌药物的非临床研究〕 S10 Photosafety Evaluation〔光平安性研究〕 S11 Nonclinical Safety Testing〔非临床平安性试验〕 Efficacy Guidelines 有效性 E1 Clinical Safety for Drugs used in Long-Term Treatment〔长期用药的临床平安性〕 E2 Pharmacovigilance〔药物警戒〕 E3 Clinical ...
INTRODUCTION 介绍 Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. In the pharmaceutical sector, the principles and framework of ICH Q9...
医药-ich q9中文版.pdf,人用药注册技术要求国际协调会议 质量风险管理 原文:2005 年十一月 9 日版 翻译:徐禾丰 英-汉对照版 2009 年五月,第五版 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN US