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Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility

  1. MUSUAMBA TSHINANU, FLORA ORCID logo
  2. Rusten, Ine Blankenberg Skottheim ORCID logo
  3. Lesage, Raphaëlle ORCID logo
  4. Russo, Giulia ORCID logo
  5. Bursi, Roberta ORCID logo
  6. Emili, Luca ORCID logo
  7. Wangorsch, Gaby ORCID logo
  8. Manolis, Efthymios
  9. Karlsson, Kristin ORCID logo
  10. Kulesza, Alexander ORCID logo
  11. Courcelles, Eulalie ORCID logo
  12. Boissel, Jean-Pierre ORCID logo
  13. Rousseau, Cécile F.
  14. Voisin, Emmanuelle M.
  15. Alessandrello, Rossana ORCID logo
  16. Curado, Nuno
  17. Dall'Ara, Enrico ORCID logo
  18. Rodriguez, Blanca ORCID logo
  19. Pappalardo, Francesco ORCID logo
  20. geris, liesbet ORCID logo

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WeightNameValue
1000 Titel
  • Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility
1000 Autor/in
  1. MUSUAMBA TSHINANU, FLORA |
  2. Rusten, Ine Blankenberg Skottheim |
  3. Lesage, Raphaëlle |
  4. Russo, Giulia |
  5. Bursi, Roberta |
  6. Emili, Luca |
  7. Wangorsch, Gaby |
  8. Manolis, Efthymios |
  9. Karlsson, Kristin |
  10. Kulesza, Alexander |
  11. Courcelles, Eulalie |
  12. Boissel, Jean-Pierre |
  13. Rousseau, Cécile F. |
  14. Voisin, Emmanuelle M. |
  15. Alessandrello, Rossana |
  16. Curado, Nuno |
  17. Dall'Ara, Enrico |
  18. Rodriguez, Blanca |
  19. Pappalardo, Francesco |
  20. geris, liesbet |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-07-13
1000 Erschienen in
1000 Quellenangabe
  • 10(8):804-825
1000 FRL-Sammlung
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1002/psp4.12669 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8376137/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • The value of in silico methods in drug development and evaluation has been demonstrated repeatedly and convincingly. While their benefits are now unanimously recognized, international standards for their evaluation, accepted by all stakeholders involved, are still to be established. In this white paper, we propose a risk-informed evaluation framework for mechanistic model credibility evaluation. To properly frame the proposed verification and validation activities, concepts such as context of use, regulatory impact and risk-based analysis are discussed. To ensure common understanding between all stakeholders, an overview is provided of relevant in silico terminology used throughout this paper. To illustrate the feasibility of the proposed approach, we have applied it to three real case examples in the context of drug development, using a credibility matrix currently being tested as a quick-start tool by regulators. Altogether, this white paper provides a practical approach to model evaluation, applicable in both scientific and regulatory evaluation contexts.
1000 Sacherschließung
gnd 4143176-5 Arzneimittelentwicklung
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
  1. https://orcid.org/0000-0001-8276-8870|https://orcid.org/0000-0003-0339-4968|https://orcid.org/0000-0003-1041-2407|https://orcid.org/0000-0001-6616-7856|https://orcid.org/0000-0001-8297-8587|https://orcid.org/0000-0001-6078-8766|https://orcid.org/0000-0003-3200-5394|https://frl.publisso.de/adhoc/uri/IE1hbm9saXMsIEVmdGh5bWlvcyAgICAg|https://orcid.org/0000-0003-4780-1166|https://orcid.org/0000-0002-8812-8548|https://orcid.org/0000-0002-8834-7265|https://orcid.org/0000-0001-8938-2284|https://frl.publisso.de/adhoc/uri/ICBSb3Vzc2VhdSwgQ8OpY2lsZSBGLiAgICAgIA==|https://frl.publisso.de/adhoc/uri/Vm9pc2luLCBFbW1hbnVlbGxlIE0uICAgIA==|https://orcid.org/0000-0001-7808-5268|https://frl.publisso.de/adhoc/uri/ICBDdXJhZG8sIE51bm8gIA==|https://orcid.org/0000-0003-1471-5077|https://orcid.org/0000-0001-6361-3339|https://orcid.org/0000-0003-1668-3320|https://orcid.org/0000-0002-8180-1445
1000 Hinweis
  • Correction added on 19 November 2021, after online publication: The legal statement was modified in this version
1000 Label
1000 Förderer
  1. Horizon 2020 |
  2. Wellcome Trust |
  3. National Centre for the Replacement, Refinement and Reduction of Animals in Research |
  4. Innovative Medicines Initiative |
1000 Fördernummer
  1. 825843; 777123; 101016503; 101017578; 101016496; ERC CoG 772418
  2. 214290/Z/18/Z
  3. NC/P001076/1
  4. 116030
1000 Förderprogramm
  1. -
  2. Fellowship in Basic Biomedical Sciences
  3. Infrastructure for Impact Award
  4. -
1000 Dateien
1000 Förderung
  1. 1000 joinedFunding-child
    1000 Förderer Horizon 2020 |
    1000 Förderprogramm -
    1000 Fördernummer 825843; 777123; 101016503; 101017578; 101016496; ERC CoG 772418
  2. 1000 joinedFunding-child
    1000 Förderer Wellcome Trust |
    1000 Förderprogramm Fellowship in Basic Biomedical Sciences
    1000 Fördernummer 214290/Z/18/Z
  3. 1000 joinedFunding-child
    1000 Förderer National Centre for the Replacement, Refinement and Reduction of Animals in Research |
    1000 Förderprogramm Infrastructure for Impact Award
    1000 Fördernummer NC/P001076/1
  4. 1000 joinedFunding-child
    1000 Förderer Innovative Medicines Initiative |
    1000 Förderprogramm -
    1000 Fördernummer 116030
1000 Objektart article
1000 Beschrieben durch
1000 @id frl:6432071.rdf
1000 Erstellt am 2022-03-09T09:58:29.390+0100
1000 Erstellt von 323
1000 beschreibt frl:6432071
1000 Bearbeitet von 25
1000 Zuletzt bearbeitet Tue Mar 29 14:46:02 CEST 2022
1000 Objekt bearb. Tue Mar 29 14:45:52 CEST 2022
1000 Vgl. frl:6432071
1000 Oai Id
  1. oai:frl.publisso.de:frl:6432071 |
1000 Sichtbarkeit Metadaten public
1000 Sichtbarkeit Daten public
1000 Gegenstand von

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