促甲状腺激素α的质量变化。

Contact in context Pub Date : 2023-01-01 Epub Date: 2023-06-20 DOI:10.6084/m9.figshare.23524530
James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Cristian Samano-Garcia, Robert A Lodder
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引用次数: 0

摘要

促甲状腺激素α是一种含有人类促甲状腺激素(TSH)的异二聚体糖蛋白。它被用作血清甲状腺球蛋白(Tg)检测的辅助诊断工具,在对既往接受过甲状腺切除术的分化良好的甲状腺癌患者进行随访时,可进行或不进行放射性碘成像检测。药物质量研究(DQS)发现,从四个不同批次的 Thyrogen® 中获得的 30 份样品的傅立叶变换近红外光谱存在批次间差异。这些样品分为两组(rtst=0.90,rlim=0.98,p=0.02)。此外,在这 30 个小瓶中,有一个小瓶(3%)与其他所有小瓶的多维标度相差 4.7 个标度,这表明它也代表了一种不同的材料。
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Quality Variations in Thyrotropin Alfa.

Thyrotropin alfa is a heterodimeric glycoprotein containing human thyroid stimulating hormone (TSH). It is used as an adjunctive diagnostic tool for serum thyroglobulin (Tg) testing with or without radioiodine imaging in the follow-up of patients with well-differentiated thyroid cancer who have previously undergone thyroidectomy. Inter-lot variability in the Fourier transform near-infrared spectra of 30 samples obtained from four separate lots of Thyrogen® was detected in the Drug Quality Study (DQS). The vials fell into two distinct groups (rtst = 0.90, rlim= 0.98, p=0.02). In addition, one vial of the 30 (3%) appeared 4.7 multidimensional SDs from all of the other vials, suggesting that it also represents a different material.

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