ArticleFrontiers in immunology2025
Immunogenicity risk assessment of peptide-related impurities identified in generic teriparatide products.
Article in Frontiers in immunology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed.
- Reduced T cell epitope cross-conservation and immunogenic potential is associated with emergence of a dominant influenza subclade K in 2025.Human vaccines & immunotherapeutics · 2026Article
- Immunogenicity of Generic Peptide Impurities: Current Orthogonal Approaches.Pharmaceutical research · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Teriparatide is one of several generic peptides named in a recent Food and Drug Administration (FDA) guidance (FDA-2017-D-5767-0002), which outlines a potential strategy to inform immunogenicity risk assessment for synthetic generic peptides without requiring clinical studies. Specifically, the guidance states that for abbreviated new drug applications (ANDAs), once the sameness of the active pharmaceutical ingredient (API) between the generic product and the reference listed drug is established, developers can mitigate the residual risk of unwanted immunogenicity response by using
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Registered trials
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