{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T09:54:12Z","timestamp":1781690052042,"version":"3.54.5"},"reference-count":43,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,5,31]],"date-time":"2026-05-31T00:00:00Z","timestamp":1780185600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,5,31]],"date-time":"2026-05-31T00:00:00Z","timestamp":1780185600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["CPT Pharmacom &amp; Syst Pharma"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    To support a post\u2010marketing requirement for pharmacokinetic (PK)\u2010focused assessments in patients ages 2\u201316\u2009years, a model\u2010informed drug development approach was used to overcome enrollment barriers in recruiting pediatric subjects with primary immune deficiency (PID) disorders under Age 6 in a Phase 4 pediatric study. Models (1) characterized total immunoglobulin G (IgG) PK of Immune Globulin Intravenous [Human], 10% Liquid [IVIG] (BIVIGAM) in children and adolescents with PID; (2) quantified the impact of age and body weight; and (3) compared simulated exposure of IVIG between pediatric and adult subjects. Models were developed using pooled adult and pediatric data from 2 Phase 3\/4 studies in 79 subjects (1243 IgG levels) with 3, 9, 13, and 54 subjects 2 to &lt;\u20096\u2009years, 6 to &lt;\u200912\u2009years, 12\u201316\u2009years, and &gt;\u200916\u2009years, respectively. Serum IgG PK of IVIG following intravenous infusion was characterized using a 2\u2010compartment PK model with body weight on total IgG clearance and volumes of distribution. Model\u2010based clearance values when estimating allometric exponents were comparable across age\u2010group categories. Simulations predicted trough IgG levels for a virtual population of subjects for recommended IVIG 10% dosages of 300\u2013800\u2009mg\/kg. Fixed and estimated allometric scaling allowed conservative extrapolation with simulations showing \u2265\u200990% of subjects would achieve trough levels \u2265\u20095\u2009g\/L (minimum recommended level) for a mid\u2010range dose of 500\u2009mg\/kg. Modeling and simulation were integral in confirming achievement of clinically acceptable trough IgG levels (~7\u2009g\/L) to support supplemental PK, efficacy, and dosing recommendations for patients \u2265\u20092\u2009years of age.\n                    <jats:bold>Trail Registration:<\/jats:bold>\n                    NCT00538915 and NCT03164967\n                  <\/jats:p>","DOI":"10.1002\/psp4.70275","type":"journal-article","created":{"date-parts":[[2026,5,31]],"date-time":"2026-05-31T15:40:33Z","timestamp":1780242033000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic Model Based Sensitivity Analysis to Lower Recruitment Burden for Young Children Requiring Intravenous Immunoglobulin G Replacement"],"prefix":"10.1002","volume":"15","author":[{"given":"Todd","family":"Dumas","sequence":"first","affiliation":[{"name":"Certara USA  Radnor Pennsylvania 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