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Author : OECD
Publisher : OECD Publishing
Page : 206 pages
File Size : 48,40 MB
Release : 2018-12-10
Category :
ISBN : 9264304797
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which ...
Author : Organisation for Economic Co-operation and Development
Publisher :
Page : 172 pages
File Size : 40,96 MB
Release : 2018
Category :
ISBN : 9789264311008
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible. Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions. GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.
Author : Organisation for Economic Co-operation and Development
Publisher :
Page : 172 pages
File Size : 21,61 MB
Release : 2018
Category :
ISBN : 9789264311015
In the past several decades, there has been a substantial increase in the availability of in vitro test methods for evaluating chemical safety in an international regulatory context. To foster confidence in in vitro alternatives to animal testing, the test methods and conditions under which data are generated must adhere to defined standards to ensure resulting data are rigorous and reproducible. Good In vitro Method Practices (GIVIMP) for the development and implementation of in vitro methods for regulatory use in human safety assessment aims to help reduce the uncertainties in cell and tissue-based in vitro method derived chemical safety predictions. GIVIMP provides guidance for test method developers and end users of resulting data on key elementes of in vitro methods. GIVIMP tackles ten important aspects related to in vitro work: (1) Roles and responsibilities, (2) Quality considerations, (3) Facilities (4) Apparatus, material and reagents, (5) Test systems, (6) Test and reference/control items, (7) Standard operating procedures (SOPs), (8) Performance of the method, (9) Reporting of results, (10) Storage and retention of records and materials.
Author : OECD
Publisher : OECD Publishing
Page : 17 pages
File Size : 46,3 MB
Release : 2017-04-13
Category :
ISBN : 9264274731
The purpose of this guidance is to harmonise the way non-guideline in vitro methods are described and thereby facilitate an assessment of the relevance of test methods for biological activities and responses of interest, and an assessment of the quality of data produced, irrespective of whether ...
Author :
Publisher :
Page : pages
File Size : 46,28 MB
Release :
Category :
ISBN :
Author : OECD
Publisher : OECD Publishing
Page : 23 pages
File Size : 17,61 MB
Release : 2017-04-13
Category :
ISBN : 9264274820
With a view to assisting the evaluation of integrated approaches to testing and assessment (IATA) in regulatory decision-making within OECD Member Countries, this guidance document provides a set of principles for reporting defined approaches to testing and assessment that can be used as one of ...
Author : OECD
Publisher : OECD Publishing
Page : 31 pages
File Size : 49,24 MB
Release : 2004-11-01
Category :
ISBN : 9264078797
This guidance document has been prepared to support technical aspects of the OECD skin absorption test guidelines. In particular is discusses the various aspects of in vivo vs. in vitro testing.
Author : OECD
Publisher : OECD Publishing
Page : 28 pages
File Size : 46,71 MB
Release : 2002-05-10
Category :
ISBN : 9264077928
This Monograph describes in detail the process of Test Guideline development, including the structure of the Test Guidelines Programme, the responsibilities of those involved and the procedures which should be followed.
Author : OECD
Publisher : OECD Publishing
Page : 39 pages
File Size : 18,31 MB
Release : 2002-05-10
Category :
ISBN : 9264078371
The purpose of this Guidance Document is to apply the principles of the Three Rs to the use of animals in regulatory toxicity tests.
Author : OECD
Publisher : OECD Publishing
Page : 29 pages
File Size : 17,36 MB
Release : 2019-06-13
Category :
ISBN : 9264932844
This document describes good practices for the licensing of protected elements included in OECD Test Guidelines (TGs). Transparency and communication are needed around protected elements resulting from innovation in sciences and techniques that are gradually integrated in OECD TGs.