James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Cristian Samano-Garcia, Robert A Lodder
{"title":"Quality Variations in Thyrotropin Alfa.","authors":"James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Cristian Samano-Garcia, Robert A Lodder","doi":"10.6084/m9.figshare.23524530","DOIUrl":null,"url":null,"abstract":"<p><p>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<sup>®</sup> was detected in the Drug Quality Study (DQS). The vials fell into two distinct groups (r<sub>tst</sub> = 0.90, r<sub>lim</sub>= 0.98, <i>p</i>=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.</p>","PeriodicalId":72698,"journal":{"name":"Contact in context","volume":"2023 ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10312997/pdf/nihms-1910673.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Contact in context","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.6084/m9.figshare.23524530","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/6/20 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
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Abstract
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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