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References from Pediatric Developmental Safety Assessment and New Approach Methodologies: US FDA/Triangle CERSI Workshop Report. Local targets link to admitted publications; unresolved targets remain external evidence.
10.1002/cpt.70148
10.1002/cpt.70148 · External reference
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Reducing safety‐related drug attrition: the use of in vitro pharmacological profiling
10.1038/nrd3845 · 2012 · External reference
The state of the art in secondary pharmacology and its impact on the safety of new medicines
10.1038/s41573-024-00942-3 · 2024 · External reference
Shaping secondary pharmacology panels of the future: evolving target selection criteria for safety panels
10.1038/s41573-025-01184-7 · 2025 · External reference
Secondary pharmacology data to assess potential off‐target activity of new drugs: a regulatory perspective
10.1038/nrd3845-c1 · 2015 · External reference
A practical guide to secondary pharmacology in drug discovery
10.1016/j.vascn.2020.106869 · 2020 · External reference
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The human and non‐human primate developmental GTEx projects
10.1038/s41586-024-08244-9 · 2025 · External reference
Genetic variation across and within individuals
10.1038/s41576-024-00709-x · 2024 · External reference
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A database of pediatric drug effects to evaluate ontogenic mechanisms from child growth and development
10.1016/j.medj.2022.06.001 · 2022 · External reference
Predicting clinical outcomes from off‐target receptor interactions using secondary intelligence
10.1016/j.vascn.2024.107570 · 2025 · External reference
A comparison of pediatric and adult safety studies for antipsychotic and antidepressant drugs submitted to the United States Food and Drug Administration
10.1016/j.jpeds.2018.12.033 · 2019 · External reference
The rising misuse of pharmacovigilance reporting systems: a threat to evidence‐based medicine
10.1002/cpt.70180 · 2026 · External reference
Analysis of secondary pharmacology assays received by the US Food and Drug Administration
10.1016/j.vascn.2022.107205 · 2022 · External reference
From guideline to practice: three years of ICH S11 insights and recommendations
10.3389/fmed.2025.1537001 · 2025 · External reference
Pediatric developmental drug toxicity: description of juvenile animal studies in US FDA prescribing information and assessing the need for new approach methodologies
10.1002/jcph.70030 · 2025 · External reference
Opportunities and insights from pharmaceutical companies on the current use of new approach methodologies in nonclinical safety assessment
10.1016/j.drudis.2025.104328 · 2025 · External reference
Multiorgan microphysiological Systems for Drug Development: strategies, advances, and challenges
10.1002/adhm.201701000 · 2018 · External reference
Biology‐inspired dynamic microphysiological system approaches to revolutionize basic research, healthcare and animal welfare
2025 · External reference
Multi‐organ toxicity demonstration in a functional human in vitro system composed of four organs
10.1038/srep20030 · 2016 · External reference
Investigation of the effect of hepatic metabolism on off‐target cardiotoxicity in a multi‐organ human‐on‐a‐chip system
10.1016/j.biomaterials.2018.07.062 · 2018 · External reference
On the potential of in vitro organ‐chip models to define temporal pharmacokinetic‐pharmacodynamic relationships
10.1038/s41598-019-45656-4 · 2019 · External reference
A functional hiPSC‐cortical neuron differentiation and maturation model and its application to neurological disorders
10.1016/j.stemcr.2021.11.009 · 2022 · External reference
Maternal and pediatric precision in therapeutic knowledge portal (MPRINT‐KP): landscape analysis of pharmacology research in maternal and pediatric patient populations
10.1002/phar.70096 · 2026 · External reference
Identifying pediatric drug safety knowledge gaps: an integrated approach leveraging real‐world data, a biomedical Knowledge Base, and Postmarketing surveillance data
10.1002/phar.70061 · 2025 · External reference
Quantitative system pharmacology as a legitimate approach to examine extrapolation strategies used to support pediatric drug development
10.1002/psp4.12801 · 2022 · External reference
Landscape of regulatory quantitative systems pharmacology submissions to the US Food and Drug Administration: an update report
10.1002/psp4.13208 · 2024 · External reference
Systems pharmacology to predict drug toxicity: integration across levels of biological organization
10.1146/annurev-pharmtox-011112-140248 · 2013 · External reference
Quantitative systems toxicology and drug development: the DILIsym experience
10.1007/978-1-0716-2265-0_9 · 2022 · External reference
Model‐informed drug development: current US regulatory practice and future considerations
10.1002/cpt.1363 · 2019 · External reference
Population physiologically‐based pharmacokinetic modeling to determine ontogeny: a quantitative clinical pharmacology example in pediatric rare disease
10.1002/psp4.70174 · 2026 · External reference
Membrane transporters in drug development and as determinants of precision medicine
10.1038/s41573-023-00877-1 · 2024 · External reference
Quantitative proteomics in translational absorption, distribution, metabolism, and excretion and precision medicine
10.1124/pharmrev.121.000449 · 2022 · External reference
From endogenous compounds as biomarkers to plasma‐derived nanovesicles as liquid biopsy; has the Golden age of translational pharmacokinetics‐absorption, distribution, metabolism, excretion‐drug‐drug interaction science finally arrived?
10.1002/cpt.1328 · 2019 · External reference
From discovery to translation: endogenous substrates of OAT1 and OAT3 as clinical biomarkers for renal secretory function
10.1002/cpt.3719 · 2025 · External reference
Developmental expression of drug transporters and conjugating enzymes involved in enterohepatic recycling: implication for pediatric drug dosing
10.1002/cpt.3409 · 2024 · External reference
A novel human stem cell‐based biomarker assay for in vitro assessment of developmental toxicity
10.1002/bdr2.2001 · 2022 · External reference
Use of quantitative in vitro to in vivo extrapolation (QIVIVE) for the assessment of non‐combustible next‐generation product aerosols
10.3389/ftox.2024.1373325 · 2024 · External reference
Development and application of a life‐stage physiologically based pharmacokinetic (PBPK) model to the assessment of internal dose of pyrethroids in humans
10.1093/toxsci/kfz211 · 2020 · External reference
Physiologically‐based pharmacokinetic modeling to support pediatric clinical development: an IQ working group perspective on the current status and challenges
10.1002/psp4.70141 · 2026 · External reference
In vitro and computational approaches to predict developmental toxicity: integrating PBPK models with cell‐based assays
10.1016/j.taap.2025.117435 · 2025 · External reference
In vitro to in vivo extrapolation from 3D hiPSC‐derived cardiac microtissues and physiologically based pharmacokinetic modeling to inform next‐generation arrhythmia risk assessment
10.1093/toxsci/kfae079 · 2024 · External reference
Animal‐free assessment of developmental toxicity: combining PBPK modeling with the ReproTracker assay
10.1016/j.tox.2023.153684 · 2023 · External reference
10.1002/bcp.70393
10.1002/bcp.70393 · External reference
Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review
10.1038/clpt.2010.298 · 2011 · External reference
Application of PBPK modeling and simulation for regulatory decision making and its impact on US prescribing information: an update on the 2018–2019 submissions to the US FDA's Office of Clinical Pharmacology
2020 · External reference
Translation of a human‐based malaria‐on‐a‐Chip phenotypic disease model for in vivo applications
10.1002/advs.202505206 · 2025 · External reference