Summary and Validation of New Animal-Free Toxicity Tests

Leist, Marcel; Hasiwa, Nina; Daneshian, Mardas

Summary and Validation of New Animal-Free Toxicity Tests

Dateien

Leist_256469.pdfGröße: 152.96 KBDownloads: 138

Datum

2013

Open Access-Veröffentlichung

Open Access Green

Sammlungen

Biologie

Publikationstyp

Zeitschriftenartikel

Publikationsstatus

Published

Erschienen in

ALTEX Proceedings. 2013, 2(1), pp. 27-37. ISSN 2194-0479

Zusammenfassung

Alternatives to animal testing have been developed mainly in the fields of toxicology and vaccine testing. Typical examples are the evaluation of phototoxicity, eye irritation, or skin corrosion resulting from cosmetics and industrial chemicals. Examples also can be found in other biomedical areas, however, including the control of the quality of drug preparations or for the control of the production process of biologics. For regulatory purposes, the quality, transferability, and predictivity of an alternative method need to be evaluated. This procedure often is called the “validation process” of a new method. It follows defined rules, and several governmental institutions have been established to perform, supervise, or advise on this process. As this often results in a delay of method implementation, different alternatives for the evaluation of a method’s suitability and quality are subject to discussion. We describe here the principles of model development and quality control. We also give an overview of methods that have undergone validation. Strengths and shortcomings of traditional approaches are discussed, and new developments and challenges are outlined.

Fachgebiet (DDC)

570 Biowissenschaften, Biologie

Schlagwörter

validation process, OECD test guidelines, ICCVAM, ECVAM, JaCVAM

Zitieren

ISO 690

LEIST, Marcel, Nina HASIWA, Mardas DANESHIAN, 2013. Summary and Validation of New Animal-Free Toxicity Tests. In: ALTEX Proceedings. 2013, 2(1), pp. 27-37. ISSN 2194-0479

BibTex

@article{Leist2013Summa-25646,
  year={2013},
  title={Summary and Validation of New Animal-Free Toxicity Tests},
  number={1},
  volume={2},
  issn={2194-0479},
  journal={ALTEX Proceedings},
  pages={27--37},
  author={Leist, Marcel and Hasiwa, Nina and Daneshian, Mardas}
}

RDF

<rdf:RDF
    xmlns:dcterms="http://purl.org/dc/terms/"
    xmlns:dc="http://purl.org/dc/elements/1.1/"
    xmlns:rdf="http://www.w3.org/1999/02/22-rdf-syntax-ns#"
    xmlns:bibo="http://purl.org/ontology/bibo/"
    xmlns:dspace="http://digital-repositories.org/ontologies/dspace/0.1.0#"
    xmlns:foaf="http://xmlns.com/foaf/0.1/"
    xmlns:void="http://rdfs.org/ns/void#"
    xmlns:xsd="http://www.w3.org/2001/XMLSchema#" > 
  <rdf:Description rdf:about="https://kops.uni-konstanz.de/server/rdf/resource/123456789/25646">
    <dcterms:available rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2014-01-15T20:22:09Z</dcterms:available>
    <bibo:uri rdf:resource="http://kops.uni-konstanz.de/handle/123456789/25646"/>
    <dc:rights>terms-of-use</dc:rights>
    <dcterms:issued>2013</dcterms:issued>
    <dcterms:abstract xml:lang="eng">Alternatives to animal testing have been developed mainly in the fields of toxicology and vaccine testing. Typical examples are the evaluation of phototoxicity, eye irritation, or skin corrosion resulting from cosmetics and industrial chemicals. Examples also can be found in other biomedical areas, however, including the control of the quality of drug preparations or for the control of the production process of biologics. For regulatory purposes, the quality, transferability, and predictivity of an alternative method need to be evaluated. This procedure often is called the “validation process” of a new method. It follows defined rules, and several governmental institutions have been established to perform, supervise, or advise on this process. As this often results in a delay of method implementation, different alternatives for the evaluation of a method’s suitability and quality are subject to discussion. We describe here the principles of model development and quality control. We also give an overview of methods that have undergone validation. Strengths and shortcomings of traditional approaches are discussed, and new developments and challenges are outlined.</dcterms:abstract>
    <dc:creator>Daneshian, Mardas</dc:creator>
    <void:sparqlEndpoint rdf:resource="http://localhost/fuseki/dspace/sparql"/>
    <dcterms:hasPart rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/25646/2/Leist_256469.pdf"/>
    <dc:creator>Leist, Marcel</dc:creator>
    <dcterms:rights rdf:resource="https://rightsstatements.org/page/InC/1.0/"/>
    <dcterms:title>Summary and Validation of New Animal-Free Toxicity Tests</dcterms:title>
    <dc:creator>Hasiwa, Nina</dc:creator>
    <dcterms:isPartOf rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:contributor>Hasiwa, Nina</dc:contributor>
    <dspace:isPartOfCollection rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:date rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2014-01-15T20:22:09Z</dc:date>
    <foaf:homepage rdf:resource="http://localhost:8080/"/>
    <dc:language>eng</dc:language>
    <dcterms:bibliographicCitation>ALTEX Proceedings ; 2 (2013), 1. - S. 27-37</dcterms:bibliographicCitation>
    <dc:contributor>Daneshian, Mardas</dc:contributor>
    <dc:contributor>Leist, Marcel</dc:contributor>
    <dspace:hasBitstream rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/25646/2/Leist_256469.pdf"/>
  </rdf:Description>
</rdf:RDF>

Universitätsbibliographie

Ja