Good Clinical Laboratory Practice (良好的临床实验室规范) 1. 引言 良好的临床实验室规范(Good Clinical Laboratory Practice,GCLP)是一套用于指导和规范临床实验室操作的准则。其目的是确保实验室数据的准确性、可靠性和一致性,以支持临床试验结果的可信度和有效性。本文将介绍GCLP的重要性、原则、具体要求以及实施...
内容提示: Good Clinical Laboratory Practice (GCLP)An international quality system for laboratories which undertake the analysis of samples from clinical trialsVanessa Grant and Tim Stiles VERSION 2 文档格式:PDF | 页数:36 | 浏览次数:495 | 上传日期:2016-04-01 03:11:01 | 文档星级: ...
需要金币:*** 金币(10金币=人民币1元) E6(R2)-Good-Clinical-Practice--Integrated-Addendum-to-ICH-E6(R1)良好临床实践ICH-E6(R1)的综合附录.pdf 关闭预览 想预览更多内容,点击免费在线预览全文 免费在线预览全文 E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry ...
GoodClinicalLaboratoryPractice(GCLP):QualityDemandingfromClinicalLaboratoriesBangladeshJMedMicrobiol2010;04(01):1-5BangladeshSocietyofMedicalMicrobiologistsEditorial1* Correspondence: Dr.ChandanKumarRoy AssistantProfessor DepartmentofClinicalPathology BangabandhuSheikhMujibMedicalUniversity Shahbag,Dhaka-1000. e-mail:chand...
In 2006, WHO/TDR convened a meeting of organizations engaged in clinical trials in disease endemic countries to discuss the applicability of GCLP guidelines to their work. It was agreed that GCLP would be a valuable tool for improving quality laboratory practice. In line with that agreement, TDR...
1. GOOD CLINICAL LABORATORY PRACTICE (GCLP): THE NEED FOR A HYBRID OF GOOD LABORATORY PRACTICE AND GOOD CLINICAL PRACTICE GUIDELINES/STANDARDS FOR MEDICAL TESTING LABORATORIES CONDUCTING CLINICAL TRIALS IN DEVELOPING COUNTRIES [J] . W. Stevens Quality Assurance . 2003,第2期 机译:良好的临床实验...
Good Clinical Practice:Consolidated Guideline.pdf,ICH E6 GCP: Consolidated Guideline: Investigator 1/7 Institutional Review Board Services ICH HARMONIZED TRIPARTITE GUIDELINE E6: GOOD CLINICAL PRACTICE: CONSOLIDATED GUIDELINE 4. INVESTIGATOR 4.1 Investi
The term GxP is a general abbreviation for 'good practice' guidelines and regulations. The 'x' represents a particular field—clinical (GCP), manufacturing (GMP), distribution (GDP), laboratory (GLP), agriculture (GAP), and so on. There is no single regulatory entity or administration; each...
Stevens W: Good Clinical Laboratory Practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines /standards for medical testing laboratories conducting clinical trials in developing countries. Qual Assur 2003, 10:83-89....
DAIDS Guidelines for Good Clinical Laboratory Practice Standards Public Health Services National Institutes of Health Bethesda, Maryland 20892 .nih.gov Dear Site Principal Investigator and Laboratory Director: All National Institutes of Health, National Institute of Allergy and Infectious Diseases, Division ...