Applications, challenges, and outlook for PBPK modeling and simulation: a regulatory, industrial and academic perspective

W Lin, Y Chen, JD Unadkat, X Zhang, D Wu… - Pharmaceutical …, 2022 - Springer
Several regulatory guidances on the use of physiologically based pharmacokinetic (PBPK)
analyses and physiologically based biopharmaceutics model (s)(PBBM (s)) have been …

Age-related modifications in CYP-dependent drug metabolism: role of stress

M Konstandi, EO Johnson - Frontiers in Endocrinology, 2023 - frontiersin.org
Accumulating clinical evidence indicates extensive inter-individual variations in the
effectiveness and adverse effects of standard treatment protocols, which are largely …

Physiologically‐Based Pharmacokinetic Modeling for Drug Dosing in Pediatric Patients: A Tutorial for a Pragmatic Approach in Clinical Care

JEM van der Heijden, JJM Freriksen… - Clinical …, 2023 - Wiley Online Library
It is well‐accepted that off‐label drug dosing recommendations for pediatric patients should
be based on the best available evidence. However, the available traditional evidence is …

Epigenetic mechanisms contribute to intraindividual variations of drug metabolism mediated by cytochrome P450 enzymes

J Jin, X Zhong - Drug Metabolism and Disposition, 2023 - ASPET
Significant interindividual and intraindividual variations on cytochrome P450 (CYP)-
mediated drug metabolism exist in the general population globally. Genetic polymorphisms …

Intracellular spatiotemporal metabolism in connection to target engagement

J Zhang, Z Qiu, Y Zhang, G Wang, H Hao - Advanced Drug Delivery …, 2023 - Elsevier
The metabolism in eukaryotic cells is a highly ordered system involving various cellular
compartments, which fluctuates based on physiological rhythms. Organelles, as the smallest …

The role of genome sequencing in neonatal intensive care units

SF Kingsmore, FS Cole - Annual review of genomics and …, 2022 - annualreviews.org
Genetic diseases disrupt the functionality of an infant's genome during fetal–neonatal
adaptation and represent a leading cause of neonatal and infant mortality in the United …

Challenges of pediatric pharmacotherapy: A narrative review of pharmacokinetics, pharmacodynamics, and pharmacogenetics

H Watanabe, N Nagano, Y Tsuji, N Noto… - European Journal of …, 2024 - Springer
Purpose Personalized pharmacotherapy, including for the pediatric population, provides
optimal treatment and has emerged as a major trend owing to advanced drug therapeutics …

Predictive Modelling in pharmacokinetics: from in-silico simulations to personalized medicine

A Paliwal, S Jain, S Kumar, P Wal… - Expert Opinion on …, 2024 - Taylor & Francis
Introduction Pharmacokinetic parameters assessment is a critical aspect of drug discovery
and development, yet challenges persist due to limited training data. Despite advancements …

Physiologically based mechanistic insight into differential risk of valproate hepatotoxicity between children and adults: a focus on ontogeny impact

YT Huang, YM Huang, FL Kung, CJ Lin… - CPT …, 2023 - Wiley Online Library
The anticonvulsant valproic acid (VPA) despite complex pharmacokinetics has been in
clinical use for nearly 6 decades. Previous reports indicated neonates, infants, and …

Estimation of fetal-to-maternal unbound steady-state plasma concentration ratio of P-glycoprotein and/or breast cancer resistance protein substrate drugs using a …

J Peng, MK Ladumor, JD Unadkat - Drug Metabolism and Disposition, 2022 - ASPET
Pregnant women are frequently prescribed drugs to treat chronic diseases such as human
immunodeficiency virus infection, but little is known about the benefits and risks of these …