{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,24]],"date-time":"2026-10-24T12:12:44Z","timestamp":1792843964972,"version":"4.5.0"},"reference-count":40,"publisher":"The Endocrine Society","issue":"2","license":[{"start":{"date-parts":[[2020,12,12]],"date-time":"2020-12-12T00:00:00Z","timestamp":1607731200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004191","name":"Novo Nordisk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004191","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,1,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Context<\/jats:title>\n                  <jats:p>Somapacitan is a long-acting growth hormone (GH) in development for once-weekly treatment of GH deficiency (GHD). Optimal monitoring of insulin-like growth factor-I (IGF-I) levels must account for weekly IGF-I fluctuations following somapacitan administration.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>To develop and assess the reliability of linear models for predicting mean and peak IGF-I levels from samples taken on different days after dosing.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Design<\/jats:title>\n                  <jats:p>A pharmacokinetic\/pharmacodynamic model was used to simulate IGF-I data in adults and children following weekly somapacitan treatment of GHD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Setting and Patients<\/jats:title>\n                  <jats:p>39 200 IGF-I profiles were simulated with reference to data from 26 adults and 23 children with GHD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Intervention(s)<\/jats:title>\n                  <jats:p>The simulated dose range was 0.02 to 0.12 mg\/kg for adults and 0.02 to 0.16 mg\/kg for children. Simulated data with &amp;gt;4 average standard deviation score were excluded.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Main Outcome Measure(s)<\/jats:title>\n                  <jats:p>Linear models for predicting mean and peak IGF-I levels based on IGF-I samples from different days after somapacitan dose.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Robust linear relationships were found between IGF-I sampled on any day after somapacitan dose and the weekly mean (R2 &amp;gt; 0.94) and peak (R2 &amp;gt; 0.84). Prediction uncertainties were generally low when predicting mean from samples taken on any day (residual standard deviation [RSD]\u2005\u2264\u20050.36) and peak from samples taken on day 1 to 4 (RSD\u2005\u2264\u20050.34). IGF-I monitoring on day 4 and day 2 after dose provided the most accurate estimate of IGF-I mean (RSD\u2005&amp;lt;\u20050.2) and peak (RSD\u2005&amp;lt;\u20050.1), respectively.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Linear models provided a simple and reliable tool to aid optimal monitoring of IGF-I by predicting mean and peak IGF-I levels based on an IGF-I sample following dosing of somapacitan. A short visual summary of our work is available (1).<\/jats:p>\n               <\/jats:sec>","DOI":"10.1210\/clinem\/dgaa775","type":"journal-article","created":{"date-parts":[[2020,12,12]],"date-time":"2020-12-12T14:13:37Z","timestamp":1607782417000},"page":"567-576","source":"Crossref","is-referenced-by-count":35,"title":["Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan"],"prefix":"10.1210","volume":"106","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0965-9333","authenticated-orcid":false,"given":"Rasmus","family":"Juul Kildemoes","sequence":"first","affiliation":[{"name":"Quantitative Clinical Pharmacology, Novo Nordisk A\/S, S\u00f8borg, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2210-0366","authenticated-orcid":false,"given":"Michael","family":"H\u00f8jby Rasmussen","sequence":"additional","affiliation":[{"name":"Global Development, Novo Nordisk A\/S, 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