{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2023,9,19]],"date-time":"2023-09-19T07:10:56Z","timestamp":1695107456818},"reference-count":33,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2018,5,10]],"date-time":"2018-05-10T00:00:00Z","timestamp":1525910400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>In several studies with monoclonal antibodies, we observed spikes in plasma concentration profiles coinciding with a change of posture of study subjects. We hypothesized that these unexpected changes were due to fluid shifts from plasma to the interstitium. The objective of this study was to investigate size and time course of the change in total immunoglobulin G (IgG) concentration after a change in posture. Thirty\u2010two healthy subjects were enrolled. After entry in the clinic, subjects remained upright for at least 1 hour, followed by IgG sampling. Thereafter, subjects remained supine or seated (16 subjects each) for 60 minutes while IgG was sampled frequently. The within\u2010subject day\u2010to\u2010day variability of IgG measured in the same position was only 2.6%. After a change in posture from standing to supine, IgG dropped rapidly in all subjects during the first 10 minutes in the supine position (9.0% decrease) and more slowly thereafter, up to a 12.3% decrease after 60 minutes. After a change in posture from standing to sitting, the decrease in IgG was more variable and modest. After 10 minutes of sitting, IgG was 3.6% lower, and after 60 minutes IgG was 7.8% lower. Changing posture causes a bias of more than 10% in plasma concentrations of total IgG. Most of the change is reached after being 15 minutes in the same position. In clinical trials in which plasma concentrations of high\u2010molecular drugs, highly protein\u2010bound drugs, endogenous proteins, or blood cells are assessed, standardizing posture per time point is a useful approach for reducing variability.<\/jats:p>","DOI":"10.1002\/jcph.1150","type":"journal-article","created":{"date-parts":[[2018,5,10]],"date-time":"2018-05-10T17:02:07Z","timestamp":1525971727000},"page":"1340-1346","update-policy":"http:\/\/dx.doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A Change in Posture Significantly Affects Plasma Concentrations of Large Molecules Such as IgG Antibodies"],"prefix":"10.1002","volume":"58","author":[{"given":"Mattheus (Thijs)","family":"van Iersel","sequence":"first","affiliation":[{"name":"Early Development Services PRA Health Sciences  Groningen The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria I.","family":"Velinova","sequence":"additional","affiliation":[{"name":"Early Development Services PRA Health Sciences  Groningen The Netherlands"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2018,5,10]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1748-1716.1995.tb09960.x"},{"issue":"1","key":"e_1_2_10_3_1","first-page":"H68","article-title":"Fluid and protein shifts after postural changes in humans","volume":"250","author":"Hinghofer\u2010Szalkay H","year":"1986","journal-title":"Am J Physiol."},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1172\/JCI100179"},{"issue":"3","key":"e_1_2_10_5_1","first-page":"414","article-title":"Plasma volume changes with movement to supine and standing positions","volume":"45","author":"Hagan RD","year":"1978","journal-title":"J Appl Physiol Respir Environ Exerc Physiol."},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/BF00865413"},{"key":"e_1_2_10_7_1","first-page":"522","article-title":"\u00dcber die Schwankungender Serumkonzentration beim gesunden Menschen","author":"B\u00f6hme A.","year":"1911","journal-title":"Deut Arch f klin Med."},{"key":"e_1_2_10_8_1","first-page":"261","article-title":"Comportamento del siero di sangue e della diuresi nell'ortostatismo","author":"Cipriani C","year":"1925","journal-title":"Minerva med."},{"key":"e_1_2_10_9_1","unstructured":"WestgardJ.Desirable biological variation database specifications.http:\/\/www.westgard.com\/biodatabase1.htmPublished 2014. 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