Publikation:

Leveraging biomarkers and translational medicine for preclinical safety : Lessons for advancing the validation of alternatives to animal testing

Lade...
Vorschaubild

Dateien

Hartung_2-1rkxceu9bezby7.pdf
Hartung_2-1rkxceu9bezby7.pdfGröße: 1.48 MBDownloads: 70

Datum

2024

Autor:innen

King, Nicholas M. P.
Kleinstreuer, Nicole
Tagle, Danilo A.

Herausgeber:innen

Kontakt

ISSN der Zeitschrift

Electronic ISSN

ISBN

Bibliografische Daten

Verlag

Schriftenreihe

Auflagebezeichnung

ArXiv-ID

Internationale Patentnummer

Angaben zur Forschungsförderung

European Union (EU): 964537
European Union (EU): 964518
European Union (EU): 963845
European Union (EU): 101057014

Projekt

Open Access-Veröffentlichung
Open Access Hybrid
Core Facility der Universität Konstanz

Gesperrt bis

Titel in einer weiteren Sprache

Publikationstyp
Zeitschriftenartikel
Publikationsstatus
Published

Erschienen in

Alternatives to Animal Experimentation : ALTEX. Springer. 2024, 41(4), S. 545-566. ISSN 1868-596X. eISSN 1868-8551. Verfügbar unter: doi: 10.14573/altex.2410011

Zusammenfassung

This article explores the potential of principles established in translational medicine for the use of bio­markers to advance the validation of alternatives to animal testing in preclinical safety assessment. It examines especially how such principles can enhance the predictive power, mechanistic under­standing, and human relevance of new approach methodologies (NAMs). Key concepts from translational medicine, such as fit-for-purpose validation, evidence-based approaches, and inte­grated testing strategies, are already being applied to the development and validation of NAMs. The article discusses challenges in implementing biomarker-based approaches, including standardi­zation, demonstration of relevance, regulatory acceptance, and addressing biological complexity. It also highlights opportunities for advancement through collaborative efforts, technological inno­vations, and regulatory evolution. Case studies demonstrate successful applications of biomarkers in preclinical safety, while future perspectives explore emerging trends like multi-omics integration, microphysiological systems, and artificial intelligence. The article emphasizes the potential of bio­markers and translational science approaches in creating more predictive, efficient, and ethical preclinical safety assessment paradigms in the use of NAMs. Use of biomarkers can enable the mechanistic validation of human-relevant models and provide a means to relate changes in NAMs to animal or clinical study results. By leveraging these tools, the field can work towards reducing reliance on animal testing while improving the accuracy and human relevance of safety predictions.

Plain language summary: This article examines how biomarkers and translational science principles can improve safety testing without using animals. Biomarkers are quantifiable indicators of biological processes. Some of these can predict disease progression or drug effects. Translational science aims to apply laboratory findings towards clinical benefits. The article explores how combining these approaches can create better, more human-relevant and validated alternatives to animal testing. It discusses challenges that the field faces, including standardization of methods and getting regulatory acceptance. It also highlights opportunities, like integration with emerging technologies and increased global collabo­ration. The ultimate goal is to improve human health by streamlining NAM validation processes, i.e., show that new safety tests are more accurate, efficient, and ethical than current animal-based methods.

Zusammenfassung in einer weiteren Sprache

Fachgebiet (DDC)
570 Biowissenschaften, Biologie

Schlagwörter

biomarkers, translational medicine, translational research, translational science, alternative methods, preclinical safety, new approach methodologies, regulatory acceptance, in vitro models, artificial intelligence

Konferenz

Rezension
undefined / . - undefined, undefined

Forschungsvorhaben

Organisationseinheiten

Zeitschriftenheft

Zugehörige Datensätze in KOPS

Zitieren

ISO 690HARTUNG, Thomas, Nicholas M. P. KING, Nicole KLEINSTREUER, Marcel LEIST, Danilo A. TAGLE, 2024. Leveraging biomarkers and translational medicine for preclinical safety : Lessons for advancing the validation of alternatives to animal testing. In: Alternatives to Animal Experimentation : ALTEX. Springer. 2024, 41(4), S. 545-566. ISSN 1868-596X. eISSN 1868-8551. Verfügbar unter: doi: 10.14573/altex.2410011
BibTex
@article{Hartung2024Lever-71168,
  year={2024},
  doi={10.14573/altex.2410011},
  title={Leveraging biomarkers and translational medicine for preclinical safety : Lessons for advancing the validation of alternatives to animal testing},
  number={4},
  volume={41},
  issn={1868-596X},
  journal={Alternatives to Animal Experimentation : ALTEX},
  pages={545--566},
  author={Hartung, Thomas and King, Nicholas M. P. and Kleinstreuer, Nicole and Leist, Marcel and Tagle, Danilo A.}
}
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/123456789/71168">
    <dc:creator>Tagle, Danilo A.</dc:creator>
    <dcterms:title>Leveraging biomarkers and translational medicine for preclinical safety : Lessons for advancing the validation of alternatives to animal testing</dcterms:title>
    <dc:contributor>Hartung, Thomas</dc:contributor>
    <dspace:isPartOfCollection rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:creator>Kleinstreuer, Nicole</dc:creator>
    <dc:creator>Leist, Marcel</dc:creator>
    <dc:contributor>Kleinstreuer, Nicole</dc:contributor>
    <bibo:uri rdf:resource="https://kops.uni-konstanz.de/handle/123456789/71168"/>
    <dc:contributor>Tagle, Danilo A.</dc:contributor>
    <dc:contributor>Leist, Marcel</dc:contributor>
    <dc:date rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2024-11-08T11:01:48Z</dc:date>
    <void:sparqlEndpoint rdf:resource="http://localhost/fuseki/dspace/sparql"/>
    <dc:creator>King, Nicholas M. P.</dc:creator>
    <dcterms:issued>2024</dcterms:issued>
    <dcterms:isPartOf rdf:resource="https://kops.uni-konstanz.de/server/rdf/resource/123456789/28"/>
    <dc:language>eng</dc:language>
    <foaf:homepage rdf:resource="http://localhost:8080/"/>
    <dspace:hasBitstream rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/71168/4/Hartung_2-1rkxceu9bezby7.pdf"/>
    <dc:contributor>King, Nicholas M. P.</dc:contributor>
    <dc:creator>Hartung, Thomas</dc:creator>
    <dcterms:hasPart rdf:resource="https://kops.uni-konstanz.de/bitstream/123456789/71168/4/Hartung_2-1rkxceu9bezby7.pdf"/>
    <dcterms:available rdf:datatype="http://www.w3.org/2001/XMLSchema#dateTime">2024-11-08T11:01:48Z</dcterms:available>
    <dc:rights>terms-of-use</dc:rights>
    <dcterms:abstract>This article explores the potential of principles established in translational medicine for the use of bio­markers to advance the validation of alternatives to animal testing in preclinical safety assessment. It examines especially how such principles can enhance the predictive power, mechanistic under­standing, and human relevance of new approach methodologies (NAMs). Key concepts from translational medicine, such as fit-for-purpose validation, evidence-based approaches, and inte­grated testing strategies, are already being applied to the development and validation of NAMs. The article discusses challenges in implementing biomarker-based approaches, including standardi­zation, demonstration of relevance, regulatory acceptance, and addressing biological complexity. It also highlights opportunities for advancement through collaborative efforts, technological inno­vations, and regulatory evolution. Case studies demonstrate successful applications of biomarkers in preclinical safety, while future perspectives explore emerging trends like multi-omics integration, microphysiological systems, and artificial intelligence. The article emphasizes the potential of bio­markers and translational science approaches in creating more predictive, efficient, and ethical preclinical safety assessment paradigms in the use of NAMs. Use of biomarkers can enable the mechanistic validation of human-relevant models and provide a means to relate changes in NAMs to animal or clinical study results. By leveraging these tools, the field can work towards reducing reliance on animal testing while improving the accuracy and human relevance of safety predictions.


Plain language summary:
This article examines how biomarkers and translational science principles can improve safety testing without using animals. Biomarkers are quantifiable indicators of biological processes. Some of these can predict disease progression or drug effects. Translational science aims to apply laboratory findings towards clinical benefits. The article explores how combining these approaches can create better, more human-relevant and validated alternatives to animal testing. It discusses challenges that the field faces, including standardization of methods and getting regulatory acceptance. It also highlights opportunities, like integration with emerging technologies and increased global collabo­ration. The ultimate goal is to improve human health by streamlining NAM validation processes, i.e., show that new safety tests are more accurate, efficient, and ethical than current animal-based methods.</dcterms:abstract>
    <dcterms:rights rdf:resource="https://rightsstatements.org/page/InC/1.0/"/>
  </rdf:Description>
</rdf:RDF>

Interner Vermerk

xmlui.Submission.submit.DescribeStep.inputForms.label.kops_note_fromSubmitter

Kontakt
URL der Originalveröffentl.

Prüfdatum der URL

Prüfungsdatum der Dissertation

Finanzierungsart

Kommentar zur Publikation

Allianzlizenz
Corresponding Authors der Uni Konstanz vorhanden
Internationale Co-Autor:innen
Universitätsbibliographie
Ja
Begutachtet
Ja
Diese Publikation teilen