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Immunogenicity risk assessment of peptide-related impurities identified in generic teriparatide products.

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Title: Immunogenicity risk assessment of peptide-related impurities identified in generic teriparatide products.
Authors: Mattei AE; EpiVax Inc, Providence, RI, United States., Roberts BJ; EpiVax Inc, Providence, RI, United States., Lelias S; EpiVax Inc, Providence, RI, United States., Miah S; EpiVax Inc, Providence, RI, United States., Howard KE; Division of Applied Regulatory Sciences, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, MD, United States., Weaver JL; Division of Applied Regulatory Sciences, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, MD, United States., Verthelyi D; Office of Pharmaceutical Quality Research-Division IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States., Pang ES; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, MD, United States., Edwards K; CUBRC, Buffalo, NY, United States., De Groot AS; EpiVax Inc, Providence, RI, United States.
Source: Frontiers in immunology [Front Immunol] 2025 Dec 08; Vol. 16, pp. 1730346. Date of Electronic Publication: 2025 Dec 08 (Print Publication: 2025).
Publication Type: Journal Article
Journal Info: Publisher: Frontiers Research Foundation] Country of Publication: Switzerland NLM ID: 101560960 Publication Model: eCollection Cited Medium: Internet ISSN: 1664-3224 (Electronic) Linking ISSN: 16643224 NLM ISO Abbreviation: Front Immunol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <searchLink fieldCode="AU" term="%22Mattei+AE%22">Mattei AE</searchLink>; EpiVax Inc, Providence, RI, United States.<br /><searchLink fieldCode="AU" term="%22Roberts+BJ%22">Roberts BJ</searchLink>; EpiVax Inc, Providence, RI, United States.<br /><searchLink fieldCode="AU" term="%22Lelias+S%22">Lelias S</searchLink>; EpiVax Inc, Providence, RI, United States.<br /><searchLink fieldCode="AU" term="%22Miah+S%22">Miah S</searchLink>; EpiVax Inc, Providence, RI, United States.<br /><searchLink fieldCode="AU" term="%22Howard+KE%22">Howard KE</searchLink>; Division of Applied Regulatory Sciences, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, MD, United States.<br /><searchLink fieldCode="AU" term="%22Weaver+JL%22">Weaver JL</searchLink>; Division of Applied Regulatory Sciences, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, MD, United States.<br /><searchLink fieldCode="AU" term="%22Verthelyi+D%22">Verthelyi D</searchLink>; Office of Pharmaceutical Quality Research-Division IV, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, United States.<br /><searchLink fieldCode="AU" term="%22Pang+ES%22">Pang ES</searchLink>; Division of Therapeutic Performance I, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, Silver Spring, MD, United States.<br /><searchLink fieldCode="AU" term="%22Edwards+K%22">Edwards K</searchLink>; CUBRC, Buffalo, NY, United States.<br /><searchLink fieldCode="AU" term="%22De+Groot+AS%22">De Groot AS</searchLink>; EpiVax Inc, Providence, RI, United States.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Frontiers+Research+Foundation]%22">Frontiers Research Foundation] </searchLink><i>Country of Publication: </i>Switzerland <i>NLM ID: </i>101560960 <i>Publication Model: </i>eCollection <i>Cited Medium: </i>Internet <i>ISSN: </i>1664-3224 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2216643224%22">16643224 </searchLink><i>NLM ISO Abbreviation: </i>Front Immunol <i>Subsets: </i>MEDLINE
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        Text: English
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              Text: 2025 Dec 08
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