IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials.
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| Title: | IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials. |
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| Authors: | Steplewski K; GSK, Collegeville, PA, USA.; BridgeBio Inc., San Francisco, CA, USA., Walker L; GSK HQ, 79 New Oxford Street, London, UK., Coffee N; Sanofi, 450 Water Street, Cambridge, MA, 02141, USA. Nefeteria.Coffee@sanofi.com., Fallon M; Daiichi Sankyo UK Ltd., Uxbridge, UK., Yonemochi R; Daiichi Sankyo (China) Holdings Co., LTD, Shanghai, China., Alpers D; Washington University School of Medicine, St Louis, MO, USA., Rockey D; Digestive Disease Research Center, Charleston, SC, USA., Lewis J; Division of Gastroenterology, Georgetown University, Washington, DC, USA., Cohen E; Pharmacovigilance and Patient Safety, AbbVie Inc., North Chicago, IL, USA., Caminis J; Gilead Oncology, Patient Safety, US Parsippany, Parsippany, NJ, USA., Hey-Hadavi J; Pfizer, New York, NY, USA., Andrade RJ; Gastroenterology Service, University Hospital-IBIMA, CIBERehd, Málaga, Spain., Palmer M; Liver Consulting LLC New York, New York, NY, USA. |
| Source: | Drug safety [Drug Saf] 2025 Aug; Vol. 48 (8), pp. 855-874. Date of Electronic Publication: 2025 Apr 03. |
| Publication Type: | Consensus Statement; Journal Article |
| Journal Info: | Publisher: Adis, Springer International Country of Publication: New Zealand NLM ID: 9002928 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1179-1942 (Electronic) Linking ISSN: 01145916 NLM ISO Abbreviation: Drug Saf Subsets: MEDLINE |
| Database: | MEDLINE Ultimate |
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| Header | DbId: mdl DbLabel: MEDLINE Ultimate An: 40178787 AccessLevel: 2 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
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| Items | – Name: Title Label: Title Group: Ti Data: IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AU" term="%22Steplewski+K%22">Steplewski K</searchLink>; GSK, Collegeville, PA, USA.; BridgeBio Inc., San Francisco, CA, USA.<br /><searchLink fieldCode="AU" term="%22Walker+L%22">Walker L</searchLink>; GSK HQ, 79 New Oxford Street, London, UK.<br /><searchLink fieldCode="AU" term="%22Coffee+N%22">Coffee N</searchLink>; Sanofi, 450 Water Street, Cambridge, MA, 02141, USA. Nefeteria.Coffee@sanofi.com.<br /><searchLink fieldCode="AU" term="%22Fallon+M%22">Fallon M</searchLink>; Daiichi Sankyo UK Ltd., Uxbridge, UK.<br /><searchLink fieldCode="AU" term="%22Yonemochi+R%22">Yonemochi R</searchLink>; Daiichi Sankyo (China) Holdings Co., LTD, Shanghai, China.<br /><searchLink fieldCode="AU" term="%22Alpers+D%22">Alpers D</searchLink>; Washington University School of Medicine, St Louis, MO, USA.<br /><searchLink fieldCode="AU" term="%22Rockey+D%22">Rockey D</searchLink>; Digestive Disease Research Center, Charleston, SC, USA.<br /><searchLink fieldCode="AU" term="%22Lewis+J%22">Lewis J</searchLink>; Division of Gastroenterology, Georgetown University, Washington, DC, USA.<br /><searchLink fieldCode="AU" term="%22Cohen+E%22">Cohen E</searchLink>; Pharmacovigilance and Patient Safety, AbbVie Inc., North Chicago, IL, USA.<br /><searchLink fieldCode="AU" term="%22Caminis+J%22">Caminis J</searchLink>; Gilead Oncology, Patient Safety, US Parsippany, Parsippany, NJ, USA.<br /><searchLink fieldCode="AU" term="%22Hey-Hadavi+J%22">Hey-Hadavi J</searchLink>; Pfizer, New York, NY, USA.<br /><searchLink fieldCode="AU" term="%22Andrade+RJ%22">Andrade RJ</searchLink>; Gastroenterology Service, University Hospital-IBIMA, CIBERehd, Málaga, Spain.<br /><searchLink fieldCode="AU" term="%22Palmer+M%22">Palmer M</searchLink>; Liver Consulting LLC New York, New York, NY, USA. – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%229002928%22">Drug safety</searchLink> [Drug Saf] 2025 Aug; Vol. 48 (8), pp. 855-874. <i>Date of Electronic Publication: </i>2025 Apr 03. – Name: TypePub Label: Publication Type Group: TypPub Data: Consensus Statement; Journal Article – Name: TitleSource Label: Journal Info Group: Src Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Adis%2C+Springer+International%22">Adis, Springer International </searchLink><i>Country of Publication: </i>New Zealand <i>NLM ID: </i>9002928 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1179-1942 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2201145916%22">01145916 </searchLink><i>NLM ISO Abbreviation: </i>Drug Saf <i>Subsets: </i>MEDLINE |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=mdl&AN=40178787 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1007/s40264-025-01540-x Languages: – Code: eng Text: English PhysicalDescription: Pagination: StartPage: 855 Titles: – TitleFull: IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Steplewski K – PersonEntity: Name: NameFull: Walker L – PersonEntity: Name: NameFull: Coffee N – PersonEntity: Name: NameFull: Fallon M – PersonEntity: Name: NameFull: Yonemochi R – PersonEntity: Name: NameFull: Alpers D – PersonEntity: Name: NameFull: Rockey D – PersonEntity: Name: NameFull: Lewis J – PersonEntity: Name: NameFull: Cohen E – PersonEntity: Name: NameFull: Caminis J – PersonEntity: Name: NameFull: Hey-Hadavi J – PersonEntity: Name: NameFull: Andrade RJ – PersonEntity: Name: NameFull: Palmer M IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 08 Text: 2025 Aug Type: published Y: 2025 Identifiers: – Type: issn-electronic Value: 1179-1942 Numbering: – Type: volume Value: 48 – Type: issue Value: 8 Titles: – TitleFull: Drug safety Type: main |
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