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

Author: OECD

Publisher: OECD Publishing

Published: 2018-12-10

Total Pages: 172

ISBN-13: 9264304797

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Guidance Document on Good In Vitro Method Practices (GIVIMP)

Author: Organisation for Economic Co-operation and Development

Publisher:

Published: 2018

Total Pages: 172

ISBN-13: 9789264311008

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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)

Author: Organisation for Economic Co-operation and Development

Publisher:

Published: 2018

Total Pages: 172

ISBN-13: 9789264311015

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

Author: OECD

Publisher: OECD Publishing

Published: 2017-04-13

Total Pages: 17

ISBN-13: 9264274731

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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 Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Human Endpoints for Experimental Animals Used in Safety Evaluation

Author: OECD

Publisher: OECD Publishing

Published: 2002-05-10

Total Pages: 39

ISBN-13: 9264078371

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The purpose of this Guidance Document is to apply the principles of the Three Rs to the use of animals in regulatory toxicity tests.

OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Conduct of Skin Absorption Studies

Author: OECD

Publisher: OECD Publishing

Published: 2004-11-01

Total Pages: 31

ISBN-13: 9264078797

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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.

OECD Guidelines for the Testing of Chemicals / OECD Series on Testing and Assessment Guidance Document for the Development of OECD Guidelines for Testing of Chemicals

Author: OECD

Publisher: OECD Publishing

Published: 2002-05-10

Total Pages: 28

ISBN-13: 9264077928

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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.

OECD Series on Testing and Assessment Revised Guidance Document 150 on Standardised Test Guidelines for Evaluating Chemicals for Endocrine Disruption

Author: OECD

Publisher: OECD Publishing

Published: 2018-09-03

Total Pages: 689

ISBN-13: 9264304746

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This guidance document was originally published in 2012 and updated in 2018 to reflect new and updated OECD test guidelines, as well as reflect on scientific advances in the use of test methods and assessment of the endocrine activity of chemicals.

Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU

Author: Gianni Dal Negro

Publisher: Academic Press

Published: 2021-11-18

Total Pages: 348

ISBN-13: 0128212527

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Practical Handbook on the 3Rs in the Context of the Directive 2010/63/EU provides updated information on the EU Directive 2010/63/EU, which is the European Union legislation that protects animals being used in research. EU Directive 2010/63/EU is the European Union (EU) legislation 'on the protection of animals used for scientific purposes' and is one of the most stringent ethical and welfare standards worldwide. Closes a gap in scientific literature by addressing the need for clear guidance in walking through the multifaced universe of 3Rs Offers a useful starting point for readers and scientist who approach the 3Rs for the first-time Gives insights into the harmonization of the animal research legislation across countries

Organotypic Models in Drug Development

Author: Monika Schäfer-Korting

Publisher: Springer Nature

Published: 2021-03-25

Total Pages: 325

ISBN-13: 3030700631

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This book provides latest findings in organotypic models in drug development and provides the scientific resonance needed in an emerging field of research in disciplines, such as molecular medicine, physiology, and pathophysiology. Today the research on human-based test systems has gained major interest and funding in the EU and the US has increased over the last years. Moreover, so-called 3R (reduce, replace, refine animal experiments) centres have been established worldwide.