In general there is a need for on-site monitoring, before, during, and after the trial; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigators, training and meetings, and extensive written guidance can assure appropria...
In general there is a need for on-site monitoring, before, during, and after the trial; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigators, training and meetings, and extensive written guidance can assure appropria...
S1C(R2): Dose Selection for Carcinogenicity Studies of PharmaceuticalsS1C(R2):药物致癌性试验的剂量选择阶段52008.3.11有 2S2 Genotoxicity Studies/基因毒性研究 S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human UseS2(R1):人用药物遗传毒性试验和结果分...
M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2):关于实施药物人体临床试验以及上市批准非临床安全性研究的指导原则 2009.6.11 M4 : The Common Technical Document 通用技术文件 M4 (R4): Organization of the Common...
M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals M3(R2):关于实施药物人体临床试验以及上市批准非临床安全性研究的指导原则 2009.6.11 M4 : The Common Technical Document 通用技术文件 M4 (R4): Organization of the Common...
3.S1C(R2): Dose Selection for Carcinogenicity Studies of Pharmaceuticals 药物致癌试验的剂量选择 S2 Genotoxicity Studies遗传毒性 4.S2(R1): Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use 人用药物的遗传毒性试验和数据分析指导原则 ...
ICH E6 (R2)Quality risk managementVendor oversightSmall companiesMedium companiesOne of the most significant revisions to the ICH E6 GCP Guideline in the last 20years was issued in November 2016, adopted by the EMA in December 2016 and by the FDA as a Guidance Document in March 2018. The ...
6.S3B:Pharmacokinetics:GuidanceforRepeatedDoseTissueDistributionStudies 药物代谢动力学:重复给药的组织分布研究指导原则 S4 7.S4:DurationofChronicToxicityTestinginAnimals(RodentandNonRodentToxicityTesting) 动物体内慢性毒性持续时间的检验(啮齿类和非啮齿类毒性试验) S5 8.S5(R2):DetectionofToxicitytoReproductionforMed...
ICH E6(R2)三方协调指导原则中英对照.docx,ICH 三方协调指导原则 E6 ICH GCP指导原则 INTRODUCTION 前言 Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that inv