{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T01:45:29Z","timestamp":1791769529538,"version":"4.3.4"},"reference-count":24,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T00:00:00Z","timestamp":1791676800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,10,11]],"date-time":"2026-10-11T00:00:00Z","timestamp":1791676800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Br J Clin Pharmacol"],"abstract":"<jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Population pharmacokinetic (popPK) modelling is widely used to support paediatric dose optimization, yet consensus on appropriate modelling approaches remains limited. This study compared pooled and Bayesian popPK approaches for paediatric pharmacokinetics (PK) analysis using monoclonal antibody (mAb) examples.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Paediatric and adult PK datasets were simulated using popPK models inspired by a published mepolizumab model, incorporating two clinically relevant scenarios reflecting different mechanisms of paediatric\u2013adult mAb PK differences. Six paediatric study designs were evaluated. Paediatric PK was analysed using pooled and Bayesian approaches, and model performance was assessed based on absolute prediction error (PE) and precision of population and individual PK parameters.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      When paediatric\u2013adult PK differences were explained primarily by body size, pooled approach estimated paediatric population clearance more accurately (median absolute PE: 1.1%\u20131.2% with pooled approach\n                      <jats:italic>vs<\/jats:italic>\n                      . 4.1%\u201310.4% with the Bayesian approach) and was robust across study designs. In contrast, when age\u2010related PK differences were present and paediatric sample size was small (\u2264 30 subjects), the Bayesian approach provided more accurate population clearance estimates for 11\u2010year\u2010old population (median absolute PE: 3.4%\u20138.2% with the Bayesian approach\n                      <jats:italic>vs<\/jats:italic>\n                      .7.4%\u201315.7% with pooled approach). Individual exposure estimates were comparable between modelling approaches.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In this case study based on mAbs acting on soluble targets, relative performance of pooled and Bayesian popPK approaches varied with the analysis objective, paediatric age group, ADME characteristics and paediatric study design. These findings provide practical considerations for applying pooled and Bayesian approaches in this context and may help inform the selection of popPK strategies to support model\u2010informed paediatric dosing decisions.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/bcp.70869","type":"journal-article","created":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T01:32:51Z","timestamp":1791768771000},"source":"Crossref","is-referenced-by-count":0,"title":["Comparison of pooled and Bayesian approaches for the analysis of paediatric pharmacokinetic data leveraging prior adult knowledge: A simulation case study for monoclonal antibodies against soluble targets"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2454-6388","authenticated-orcid":false,"given":"Misako","family":"Takenaka","sequence":"first","affiliation":[{"name":"Clinical pharmacology Modeling and Simulation GSK  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott","family":"Marshall","sequence":"additional","affiliation":[{"name":"Clinical pharmacology Modeling and Simulation GSK  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frances","family":"Stringer","sequence":"additional","affiliation":[{"name":"Clinical pharmacology Modeling and Simulation GSK  Abbotsford Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masanori","family":"Yamada","sequence":"additional","affiliation":[{"name":"Clinical pharmacology Modeling and Simulation GSK  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Zecchin","sequence":"additional","affiliation":[{"name":"Clinical pharmacology Modeling and Simulation GSK  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,10,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11095\u2010022\u201003288\u2010w"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2020.00571"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.addr.2024.115364"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcph.1478"},{"key":"e_1_2_10_6_1","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).ICH harmonized guideline: addendum to ICH E11: clinical investigation of medicinal products in the pediatric population ICH E11 (R1) final version.2017."},{"key":"e_1_2_10_7_1","unstructured":"ICH harmonized guideline: pediatric extrapolation E11A final version. 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