Comparison of Pooled and Bayesian population PK approaches in pediatric PK analysis leveraging prior adult knowledge: A case study exploring considerations for mAbs

Comparison of Pooled and Bayesian population PK approaches in pediatric PK analysis leveraging prior adult knowledge: A case study exploring considerations for mAbs | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 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Data may be preliminary. 12 May 2026 V1 Latest version Share on Comparison of Pooled and Bayesian population PK approaches in pediatric PK analysis leveraging prior adult knowledge: A case study exploring considerations for mAbs Authors : Misako Takenaka 0000-0002-2454-6388 [email protected] , Scott Marshall [email protected] , Frances Stringer [email protected] , Masanori Yamada [email protected] , and Chiara Zecchin [email protected] [email protected] Authors Info & Affiliations https://doi.org/10.22541/authorea.15003122/v1 12 views 5 downloads Contents Abstract Graphical Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Aim Population pharmacokinetic (popPK) modeling is widely used to support pediatric dosing within pediatric extrapolation frameworks, yet consensus on appropriate modeling approaches remains limited. This study aimed to compare Pooled and Bayesian popPK approaches for pediatric PK analysis using a monoclonal antibody (mAb) example, focusing on bias and precision of parameter estimates. Methods Pediatric and adult PK datasets were simulated based on a reference mAb popPK model under two clinically relevant scenarios reflecting different mechanisms of PK differences between pediatric and adult populations. Six pediatric study designs were evaluated. Pediatric PK was analyzed using Pooled and Bayesian popPK approaches, and model performance was assessed across repeated trials based on bias and precision of population and individual PK parameters. Results Pooled approach generally provided more precise population parameter estimates (up to 14-fold lower relative margin of error) and showed robustness to pediatric study design when PK differences were primarily explained by body size. In contrast, when age‑related PK differences were present, Bayesian approach provided higher accuracy in population parameter estimates for younger pediatric populations, reducing median absolute prediction error by up to ~70% in small studies. Individual exposure estimates were comparable between modeling approaches. Conclusion The optimal popPK approach for pediatric PK analysis depends on the analysis objective, pediatric age group of interest, mAb PK characteristics, and pediatric study design. This study identifies practical considerations for applying Pooled and Bayesian approaches and supports informed selection of popPK strategies to enable robust pediatric PK characterization and model‑informed dosing decisions. Graphical Abstract Supplementary Material File (supplemental information.docx) supplemental information Download 1.91 MB Information & Authors Information Version history V1 Version 1 12 May 2026 Collection British Journal of Clinical Pharmacology Authors Affiliations Misako Takenaka 0000-0002-2454-6388 [email protected] GSK plc, London, United Kingdom of Great Britain and Northern Ireland, WC1A 1DG View all articles by this author Scott Marshall [email protected] GSK plc, London, United Kingdom of Great Britain and Northern Ireland, WC1A 1DG View all articles by this author Frances Stringer [email protected] GSK plc, London, United Kingdom of Great Britain and Northern Ireland, WC1A 1DG View all articles by this author Masanori Yamada [email protected] GSK plc, London, United Kingdom of Great Britain and Northern Ireland, WC1A 1DG View all articles by this author Chiara Zecchin [email protected] [email protected] GSK plc, London, United Kingdom of Great Britain and Northern Ireland, WC1A 1DG View all articles by this author Metrics & Citations Metrics Article Usage 12 views 5 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Misako Takenaka, Scott Marshall, Frances Stringer, et al. Comparison of Pooled and Bayesian population PK approaches in pediatric PK analysis leveraging prior adult knowledge: A case study exploring considerations for mAbs. Authorea . 12 May 2026. DOI: https://doi.org/10.22541/authorea.15003122/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . 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