S9 Nonclinical Evaluation for Anticancer Pharmaceuticals(抗癌药物的非临床研究) S10Photosafety Evaluation(光安全性研究) S11Nonclinical Safety Testing(非临床安全性试验) Efficacy Guidelines有效性 E1Clinical Safety for Drugs used in Long-Term Treatment(长期用药的临床安全性) E2Pharmacovigilance(药物警戒) E3Clini...
This ICH IG focuses on medicinal products and therapeuticbiologicsfor human use. However, the ICH is aware of other regional applications of the messaging standard that have a wider scope, such as pharmacovigilance activities related tovaccines, herbal products, cosmetics, veterinary products or medical...
CIOMS, Current Challenges in Pharmacovigilance: Pragmatic Approaches. Report of CIOMS Working Group V. Geneva; World Health Organization (WHO), 2001. Guidelines for Good Pharmacoepidemiology Practices (GPP), International Society for Pharmacoepidemiology,http://www.pharmacoepi.org/resources/guidelines_08027...
―S‖类专题——SafetyGuidelines ―E‖类专题——EfficacyGuidelines―M‖类专题——MultidisciplinaryGuidelines ICH简介 •名称2015.10.23更名为：InternationalCouncilforHarmonisationofTechnicalRequirementsforPharmaceuticalsforHumanUse（ICH）人用药物技术要求国际协调理事会 曾用名：InternationalConferenceon...
31、afety Reports E2C(R2) Periodic Benefit-Risk Evaluation Report a36E2C(R2) -E2FE2C(R2) Q&AsQuestions & Answers: Periodic Benefit-Risk Evaluation ReportE2D Post-Approval Safety Data Management: Definitions and Standards for Expedited ReportingE2E Pharmacovigilance PlanningE2F Development Safety Update ...
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 ...
1. CIOMS, Current Challenges in Pharmacovigilance:Pragmatic Approaches.Report of CIOMS Working Group V. Geneva; World Health Organization (WHO), 2001. 2.Guidelines for Good Pharmacoepidemiology Practices (GPP), InternationalSociety for Pharmacoepidemiology, ...
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...
1. CIOMS, Current Challenges in Pharmacovigilance:Pragmatic Approaches.Report of CIOMS Working Group V. Geneva; World Health Organization (WHO), 2001. 2.Guidelines for Good Pharmacoepidemiology Practices (GPP), InternationalSociety for Pharmacoepidemiology, ...
ICH和欧盟药品风险管理指南简介 ＣｈｉｎＪＣｌｉｎＰｈａｒｍａｃｏｌ７７ＶＯＩ．２５ＮＯ．２Ｍａｒ．２．００９（ＳｅｒｉａｌＮｏ．１ １８）ＩＣＨ和欧盟药品风险管理指南简介Ｓｕｍｍａｒｉｚｅｏｆｇｕｉｄｅｌｉｎｅｓｏｎ ｄｒｕｇｒｉｓｋ ｍａｎａｇｅｍｅｎｔｐｒｏｇｒａｍｓＩＣＨａｎｄ ＥＭＥＡ唐健元（...