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Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing.

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Title: Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing.
Authors: Zhao A; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA. an.zhao@regeneron.com., Bond S; Alnylam Pharmaceuticals Inc., Cambridge, Massachusetts, USA., Clausen V; Alnylam Pharmaceuticals Inc., Cambridge, Massachusetts, USA., Chen M; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA., Lai CH; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA., Zylstra J; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA., Grimaldi C; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA., Partridge MA; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.
Source: The AAPS journal [AAPS J] 2026 May 19; Vol. 28 (4). Date of Electronic Publication: 2026 May 19.
Publication Type: Journal Article; Review
Journal Info: Publisher: American Association of Pharmaceutical Scientists Country of Publication: United States NLM ID: 101223209 Publication Model: Electronic Cited Medium: Internet ISSN: 1550-7416 (Electronic) Linking ISSN: 15507416 NLM ISO Abbreviation: AAPS J Subsets: MEDLINE
Database: MEDLINE Ultimate
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PubType: Academic Journal
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  Data: Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing.
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  Data: <searchLink fieldCode="AU" term="%22Zhao+A%22">Zhao A</searchLink>; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA. an.zhao@regeneron.com.<br /><searchLink fieldCode="AU" term="%22Bond+S%22">Bond S</searchLink>; Alnylam Pharmaceuticals Inc., Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Clausen+V%22">Clausen V</searchLink>; Alnylam Pharmaceuticals Inc., Cambridge, Massachusetts, USA.<br /><searchLink fieldCode="AU" term="%22Chen+M%22">Chen M</searchLink>; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.<br /><searchLink fieldCode="AU" term="%22Lai+CH%22">Lai CH</searchLink>; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.<br /><searchLink fieldCode="AU" term="%22Zylstra+J%22">Zylstra J</searchLink>; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.<br /><searchLink fieldCode="AU" term="%22Grimaldi+C%22">Grimaldi C</searchLink>; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.<br /><searchLink fieldCode="AU" term="%22Partridge+MA%22">Partridge MA</searchLink>; Regeneron Pharmaceuticals Inc., Tarrytown, New York, USA.
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  Data: <searchLink fieldCode="JN" term="%22101223209%22">The AAPS journal</searchLink> [AAPS J] 2026 May 19; Vol. 28 (4). <i>Date of Electronic Publication: </i>2026 May 19.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22American+Association+of+Pharmaceutical+Scientists%22">American Association of Pharmaceutical Scientists </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101223209 <i>Publication Model: </i>Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1550-7416 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2215507416%22">15507416 </searchLink><i>NLM ISO Abbreviation: </i>AAPS J <i>Subsets: </i>MEDLINE
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      – Type: doi
        Value: 10.1208/s12248-026-01260-9
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      – Code: eng
        Text: English
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      – TitleFull: Immunogenicity Assessment for siRNA Therapeutics: A Risk-Based Proposal for Event-Driven Testing.
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            NameFull: Zhao A
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              Text: 2026 May 19
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              Y: 2026
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              Value: 28
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