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Type 1 diabetes prevention clinical trial simulator: Case reports of model-informed drug development tool.
Morales JF, Klose M, Hoffert Y, Podichetty JT, Burton J, Schmidt S, Romero K, O'Doherty I, Martin F, Campbell-Thompson M, Haller MJ, Atkinson MA, Kim S. Morales JF, et al. CPT Pharmacometrics Syst Pharmacol. 2024 Aug;13(8):1309-1316. doi: 10.1002/psp4.13193. Epub 2024 Jul 3. CPT Pharmacometrics Syst Pharmacol. 2024. PMID: 38961520 Free PMC article.
Is the GFR-based scaling approach adequate for predicting pediatric renal clearance of drugs with passive tubular reabsorption? Insights from PBPK modeling.
Li S, Ye X, Wang Q, Cheng Z, Liu F, Xie F. Li S, et al. CPT Pharmacometrics Syst Pharmacol. 2025 Jan;14(1):152-163. doi: 10.1002/psp4.13254. Epub 2024 Oct 15. CPT Pharmacometrics Syst Pharmacol. 2025. PMID: 39403008 Free PMC article.
This study investigated the adequacy of GFR-based scaling models for predicting pediatric renal clearance in drugs with passive tubular reabsorption by comparing with a mechanistic kidney model (Mech-KiM) that encompasses the physiological processes of glomerular filtratio …
This study investigated the adequacy of GFR-based scaling models for predicting pediatric renal clearance in drugs with passive tubular reab …
A computational tool to optimize clinical trial parameter selection in Duchenne muscular dystrophy: A practical guide and case studies.
Wilk J, Aggarwal V, Pauley M, Corey D, Conrado DJ, Lingineni K, Morales JF, Yoon DY, Zhang Y, Cui Z, Burton J, Larkindale J, Ma SC, Hovinga C, Martinez T, Romero K, Belfiore-Oshan R, Kim S; Duchenne Regulatory Science Consortium (D‐RSC) and the CINRG DNHS investigators. Wilk J, et al. CPT Pharmacometrics Syst Pharmacol. 2024 Nov 27. doi: 10.1002/psp4.13281. Online ahead of print. CPT Pharmacometrics Syst Pharmacol. 2024. PMID: 39600251 Free article.