OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP)

OECD Series on Testing and Assessment Guidance Document on Good In Vitro Method Practices (GIVIMP)
Author: OECD
Publisher: OECD Publishing
Total Pages: 206
Release: 2018-12-10
Genre:
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 ...

Guidance Document on Good In Vitro Method Practices (GIVIMP)

Guidance Document on Good In Vitro Method Practices (GIVIMP)
Author: Organisation for Economic Co-operation and Development
Publisher:
Total Pages: 172
Release: 2018
Genre:
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.

Guidance Document on Good In Vitro Method Practices (GIVIMP)

Guidance Document on Good In Vitro Method Practices (GIVIMP)
Author: Organisation for Economic Co-operation and Development
Publisher:
Total Pages: 172
Release: 2018
Genre:
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.

OECD Series on Testing and Assessment Guidance Document for Describing Non-Guideline In Vitro Test Methods

OECD Series on Testing and Assessment Guidance Document for Describing Non-Guideline In Vitro Test Methods
Author: OECD
Publisher: OECD Publishing
Total Pages: 17
Release: 2017-04-13
Genre:
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 ...

OECD Series on Testing and Assessment Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment

OECD Series on Testing and Assessment Guidance Document on the Reporting of Defined Approaches to be Used Within Integrated Approaches to Testing and Assessment
Author: OECD
Publisher: OECD Publishing
Total Pages: 23
Release: 2017-04-13
Genre:
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 ...

OECD Series on Testing and Assessment Guiding Principles on Good Practices for the Availability/Distribution of Protected Elements in OECD Test Guidelines

OECD Series on Testing and Assessment Guiding Principles on Good Practices for the Availability/Distribution of Protected Elements in OECD Test Guidelines
Author: OECD
Publisher: OECD Publishing
Total Pages: 29
Release: 2019-06-13
Genre:
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.