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References from Development, Early Verification and Application of a North American Pediatric PBPK Model, Comparison With the North European Pediatric Population. Local targets link to admitted publications; unresolved targets remain external evidence.
Inter‐Ethnic Differences in Pharmacokinetics‐Is There More That Unites Than Divides?
10.1002/prp2.890 · 2021 · External reference
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Prevalence of CYP3A5 Genomic Variances and Their Impact on Tacrolimus Dosing Requirements Among Kidney Transplant Recipients in Eastern North Carolina
10.1002/phar.1970 · 2017 · External reference
Regulatory Landscape With U.S. Patient Requirements and Clinical Trial Diversity Expectations
10.1016/j.conctc.2024.101331 · 2024 · External reference
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Prediction of In Vivo Drug Clearance From In Vitro Data. I: Impact of Inter‐Individual Variability
10.1080/00498250600683197 · 2006 · External reference
Prediction of In Vivo Drug Clearance From In Vitro Data. II: Potential Inter‐Ethnic Differences
10.1080/00498250600683262 · 2006 · External reference
Differences in Cytochrome p450‐Mediated Pharmacokinetics Between Chinese and Caucasian Populations Predicted by Mechanistic Physiologically Based Pharmacokinetic Modelling
10.1007/s40262-013-0089-y · 2013 · External reference
Development and Verification of Virtual Population Models for Predicting Drug Pharmacokinetics in Ethnic North American Populations
2025 · External reference
The Challenges of Pediatric Drug Development
10.1016/j.curtheres.2019.01.007 · 2019 · External reference
Prediction of the Clearance of Eleven Drugs and Associated Variability in Neonates, Infants and Children
10.2165/00003088-200645090-00005 · 2006 · External reference
Development and Verification of a Japanese Pediatric Physiologically Based Pharmacokinetic Model With Emphasis on Drugs Eliminated by Cytochrome P450 or Renal Excretion
10.1002/jcph.2317 · 2023 · External reference
Development, Verification, and Application of a Chinese Pediatric Physiologically Based Pharmacokinetic Model: Emphasis on CYP Metabolism and Renal Elimination
10.1208/s12248-025-01151-5 · 2025 · External reference
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Meta‐Analysis of Hepatic Cytochrome P450 Ontogeny to Underwrite the Prediction of Pediatric Pharmacokinetics Using Physiologically Based Pharmacokinetic Modeling
10.1002/jcph.585 · 2016 · External reference
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Morphine Clearance in Children: Does Race or Genetics Matter?
10.5055/jom.2012.0119 · 2012 · External reference
Tacrolimus Dosing Between Races in Pediatric Patients Following Heart Transplant
10.1016/j.healun.2022.01.1291 · 2022 · External reference
Atomoxetine Pharmacokinetics in Children and Adolescents With Attention Deficit Hyperactivity Disorder
10.1089/104454603321666199 · 2003 · External reference
Combination Therapy With Efavirenz, Nelfinavir, and Nucleoside Reverse‐Transcriptase Inhibitors in Children Infected With Human Immunodeficiency Virus Type 1. Pediatric AIDS Clinical Trials Group 382 Team
10.1056/nejm199912163412502 · 1999 · External reference
Efavirenz Pharmacokinetics in HIV‐1‐Infected Children Are Associated With CYP2B6‐G516T Polymorphism
10.1097/qai.0b013e318040b29e · 2007 · External reference
The Single‐Dose Pharmacokinetics of Midazolam and Its Primary Metabolite in Pediatric Patients After Oral and Intravenous Administration
10.1177/00912700122012832 · 2001 · External reference
Montelukast Dose Selection in 6‐ to 14‐Year‐Olds: Comparison of Single‐Dose Pharmacokinetics in Children and Adults
10.1177/00912709922008434 · 1999 · External reference
Characterization of Contributing Factors to Variability in Morphine Clearance Through PBPK Modeling Implemented With OCT1 Transporter
2017 · External reference
Single‐Dose Pharmacokinetics of Oral and Intravenous Pantoprazole in Children and Adolescents
10.1177/0091270008321811 · 2008 · External reference
A Phase 1 Dosing Study of Ruxolitinib in Children With Relapsed or Refractory Solid Tumors, Leukemias, or Myeloproliferative Neoplasms: A Children's Oncology Group Phase 1 Consortium Study (ADVL1011)
10.1002/pbc.25575 · 2015 · External reference
Pharmacokinetics of Intravenous Sildenafil in Children With Palliated Single Ventricle Heart Defects: Effect of Elevated Hepatic Pressures
10.1017/s1047951115000359 · 2016 · External reference
Development of a Pediatric Physiologically Based Pharmacokinetic Model for Sirolimus: Applying Principles of Growth and Maturation in Neonates and Infants
2015 · External reference
Tacrolimus Dosing in Pediatric Heart Transplant Patients Is Related to CYP3A5 and MDR1 Gene Polymorphisms
10.1034/j.1600-6143.2003.00077.x · 2003 · External reference
Current Use of Physiologically Based Pharmacokinetic Modeling in New Medicinal Product Approvals at EMA
10.1002/cpt.3525 · 2025 · External reference
The Evolution and Future Directions of PBPK Modeling in FDA Regulatory Review
10.3390/pharmaceutics17111413 · 2025 · External reference
Evaluation of Fentanyl‐Emerged Adverse Events and Pharmacokinetics in Neonates: A Physiologically Based Pharmacokinetic Modeling Approach
10.1007/s40262-025-01573-6 · 2025 · External reference
Virtual Twins: Understanding the Data Required for Model‐Informed Precision Dosing
10.1002/cpt.1778 · 2020 · External reference
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U.S. Racial and Ethnic Participation in Global Clinical Trials by Therapeutic Areas
10.1111/jcpt.13532 · 2021 · External reference
Analysis by Age, Sex, Race, and Ethnicity of Participants in Clinical Trials Supporting Recently Approved Novel Therapies
10.1002/cpt.3578 · 2025 · External reference
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Tacrolimus Troughs and Genetic Determinants of Metabolism in Kidney Transplant Recipients: A Comparison of Four Ancestry Groups
10.1111/ajt.15385 · 2019 · External reference
OCT1 Genetic Variants Influence the Pharmacokinetics of Morphine in Children
10.2217/pgs.13.94 · 2013 · External reference
Influence of OCT1 Ontogeny and Genetic Variation on Morphine Disposition in Critically Ill Neonates: Lessons From PBPK Modeling and Clinical Study
10.1002/cpt.1249 · 2019 · External reference
Effect of Genetic Variation in the Organic Cation Transporter 1, OCT1, on Metformin Pharmacokinetics
10.1038/sj.clpt.6100275 · 2008 · External reference
Racial Differences in Growth Patterns of Children Assessed on the Basis of Bone Age
10.1148/radiol.2493080468 · 2009 · External reference
Ontogeny of Human Hepatic Cytochromes P450
10.1002/jbt.20179 · 2007 · External reference
Ontogeny of Hepatic Drug Transporters as Quantified by LC‐MS/MS Proteomics
10.1002/cpt.409 · 2016 · External reference
Understanding the Relative Roles of Pharmacogenetics and Ontogeny in Pediatric Drug Development and Regulatory Science
10.1177/0091270009360533 · 2010 · External reference
Physiologically Based Pharmacokinetic Modeling of Caffeine in Preterm Neonates: Influence of Renal Function and Impairment on Dosing
10.1002/jcph.70135 · 2026 · External reference
Positive Implications of PBPK Platform Qualification for Predicting Drug‐Drug Interactions: Taking on Cracks Only to See Bigger Gaps!
10.1016/j.dmpk.2025.101514 · 2025 · External reference
