Evidence map›Paper›PMID 41306796›Full record

ArticleContact in context2025

Fourier Transform Near-Infrared Spectrometry Reveals Significant Inter-Lot Variability in Thyrotropin Alfa (Thyrogen

Uiyeol Yoon, Ayumi Tarianto, Philip J Almeter, Eleonora Hasani, Aaron N Hunter, Thomas A Lyman, Stephanie P Zapata, Bradley S Henderson, Seth A Larkin, Adler Crumrin and 14 more

Abstract read
In one paragraph

Article in Contact in context, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Uiyeol YoonDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Ayumi TariantoDepartment of Pharmaceutical Sciences, University of Kentucky, Lexington, KY 40536.
Philip J AlmeterDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Eleonora HasaniDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Aaron N HunterDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Thomas A LymanDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Stephanie P ZapataDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Bradley S HendersonDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Seth A LarkinDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Adler CrumrinDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Jerod SmithDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Spencer PergremDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Ashton PlymaleDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Bailee RamnesDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Reagan KnightDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Erin VongchanDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Samantha SchnabelDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Bailey HallDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Kyra SharpDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Madison GeibDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Abby WingateDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Alexander BacanurschiDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Ryan W NasemanDepartment of Pharmacy Services, University of Kentucky HealthCare, Lexington, KY 40536.
Robert A LodderDepartment of Pharmaceutical Sciences, University of Kentucky, Lexington, KY 40536.ORCID 0000-0001-6133-7561

Funding

Kentucky Center for Clinical and Translational ScienceUL1TR001998 · NCATS · UNIVERSITY OF KENTUCKY · PI HARTMANN, KATHERINE E, KERN, PHILIP A · 2016 to 2025
$34.2M
NCATS NIH HHS UL1 TR001998
6 · The paper itself

Abstract

Thyrotropin alfa is a recombinant heterodimeric glycoprotein that serves as a highly purified form of human thyroid stimulating hormone (TSH). It is produced through recombinant DNA technology within a genetically modified Chinese hamster ovary (CHO) cell line. The molecule is structurally complex, consisting of two non-covalently linked subunits: an alpha subunit (92 amino acid residues) with two N-linked glycosylation sites, and a beta subunit (118 residues) containing one N-linked glycosylation site. The resulting amino acid sequence is identical to that of human pituitary TSH. Thyrotropin alfa is supplied as a sterile, non-pyrogenic, white to off-white lyophilized product, intended for intramuscular (IM) administration after reconstitution with Sterile Water for Injection, USP. Each vial of Thyrogen contains 1.1 mg thyrotropin alfa, 36 mg mannitol, 5.1 mg sodium phosphate, and 2.4 mg sodium chloride. The intralot analysis of the 12 vials sampled from lot EY0155 revealed significant differences in the drug product within the same manufacturing lot, as evidenced by both spectral plots and multivariate analysis. The visual differences were observed in the following wavenumber regions: 4000 to 5000 cm

Identifiers

PMID41306796
PMCPMC12646678

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.