{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T07:01:27Z","timestamp":1793343687751,"version":"4.5.0"},"reference-count":50,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,1,11]],"date-time":"2021-01-11T00:00:00Z","timestamp":1610323200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100003093","name":"Ministry of Higher Education, Malaysia","doi-asserted-by":"publisher","award":["FRGS\/1\/2017\/SKK09\/UKM\/02\/5"],"award-info":[{"award-number":["FRGS\/1\/2017\/SKK09\/UKM\/02\/5"]}],"id":[{"id":"10.13039\/501100003093","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2021,7]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>There is considerable interpatient variability in the pharmacokinetics (PK) of intravenous immunoglobulin G (IVIG), causing difficulty in optimizing individual dosage regimen. This study aims to estimate the population PK parameters of IVIG and to investigate the impact of genetic polymorphism of the FcRn gene and clinical variability on the PK of IVIG in patients with predominantly antibody deficiencies.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients were recruited from four hospitals. Clinical data were recorded and blood samples were taken for PK and genetic studies. Population PK parameters were estimated by nonlinear mixed\u2010effects modelling in Monolix\u00ae. Models were evaluated using the difference in objective function value, goodness\u2010of\u2010fit plots, visual predictive check and bootstrap analysis. Monte Carlo simulation was conducted to evaluate different dosing regimens for IVIG.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 30 blood samples were analysed from 10 patients. The immunoglobulin G concentration data were best described by a one\u2010compartment model with linear elimination. The final model included both volume of distribution (Vd) and clearance (CL) based on patient's individual weight. Goodness\u2010of\u2010fit plots indicated that the model fit the data adequately, with minor model mis\u2010specification. Genetic polymorphism of the FcRn gene and the presence of bronchiectasis did not affect the PK of IVIG. Simulation showed that 3\u20134\u2010weekly dosing intervals were sufficient to maintain IgG levels of 5\u00a0g\u00a0L<jats:sup>\u22121<\/jats:sup>, with more frequent intervals needed to achieve higher trough levels.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Body weight significantly affects the PK parameters of IVIG. Genetic and other clinical factors investigated did not affect the disposition of IVIG.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.14712","type":"journal-article","created":{"date-parts":[[2020,12,30]],"date-time":"2020-12-30T08:33:14Z","timestamp":1609317194000},"page":"2956-2966","source":"Crossref","is-referenced-by-count":10,"title":["Population pharmacokinetic modelling of intravenous immunoglobulin in patients with predominantly antibody deficiencies"],"prefix":"10.1111","volume":"87","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8865-9093","authenticated-orcid":false,"given":"Jian Lynn","family":"Lee","sequence":"first","affiliation":[{"name":"Centre for Quality Management of Medicines, Faculty of Pharmacy Universiti Kebangsaan Malaysia  Kuala Lumpur Malaysia"},{"name":"Department of Pharmacy Tengku Ampuan Rahimah Hospital, Ministry of Health Malaysia  Klang Selangor Darul Ehsan Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6243-6975","authenticated-orcid":false,"given":"Shamin","family":"Mohd Saffian","sequence":"additional","affiliation":[{"name":"Centre for Quality Management of Medicines, Faculty of Pharmacy Universiti Kebangsaan Malaysia  Kuala Lumpur Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0592-0645","authenticated-orcid":false,"given":"Mohd","family":"Makmor\u2010Bakry","sequence":"additional","affiliation":[{"name":"Centre for Quality Management of Medicines, Faculty of Pharmacy Universiti Kebangsaan Malaysia  Kuala Lumpur Malaysia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4450-4361","authenticated-orcid":false,"given":"Farida","family":"Islahudin","sequence":"additional","affiliation":[{"name":"Centre for Quality Management of Medicines, Faculty of Pharmacy Universiti 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