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Chemical safety and biosafety

Guidance Document on Good In Vitro Method Practices (GIVIMP)

In series:OECD Series on Testing and Assessmentview more titles

Published on December 10, 2018

book
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.

TABLE OF CONTENTS

About the OECD
Foreword
Introduction
Executive summary
Scope
Roles and responsibilities
Quality considerations
Facilities
Apparatus, material and reagents
Test systems
Test and reference/control items
Standard operating procedures
Performance of the method
Reporting of results
Storage and retention of records and materials
Annexes10 chapters available
Good Cell Culture Practice (GCCP)
Good Cell Culture Practice for stem cells and stem-cell-derived models
EURL ECVAM GIVIMP meeting 24-25 February 2015 - participating experts
OECD GIVIMP meeting 23-24 March, 2017 - participating experts
Standardisation and accreditation bodies
Good Laboratory Practice
Solubility
Biokinetics and xenobiotic bioavailability
List of viability testing methods (non-inclusive) of cell cultures
Glossary
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