Simulating different dosing scenarios for a child-appropriate valproate ER formulation in a new pediatric two-stage dissolution model

F Karkossa, A Krueger, J Urbaniak, S Klein - AAPS PharmSciTech, 2017 - Springer
Predictive in vitro test methods addressing the parameters relevant to drug release in the
pediatric gastrointestinal tract could be an appropriate means for reducing the number of in …

Pharmacokinetic studies following intravenous and rectal administration of midazolam in children

GB Kraus, RG Gruber, R Knoll, U Danner - Der Anaesthesist, 1989 - europepmc.org
Conclusions The pharmacokinetics of midazolam in our patients showed a shorter half-life,
probably due to the higher hepatic clearance based on the high CI in children, as …

Midazolam oral solution (Ozalin®): a profile of its use for procedural sedation or premedication before anaesthesia in children

KA Lyseng-Williamson - Drugs & Therapy Perspectives, 2019 - Springer
Ozalin®, a novel oral solution of 0.2% midazolam, is an effective option for moderate
sedation prior to a therapeutic or diagnostic procedure, and as premedication before …

Dosage individualization in children: integration of pharmacometrics in clinical practice

W Zhao, S Leroux, E Jacqz-Aigrain - World journal of pediatrics, 2014 - Springer
Background Children are in a continuous and dynamically changing state of growth and
development. A thorough understanding of developmental pharmacokinetics (PK) and …

Clinical implications of pharmacokinetics and pharmacodynamics of procedural sedation agents in children

C Sahyoun, B Krauss - Current opinion in pediatrics, 2012 - journals.lww.com
Clinical implications of pharmacokinetics and pharmacodynami... : Current Opinion in Pediatrics
Clinical implications of pharmacokinetics and pharmacodynamics of procedural sedation agents …

Physiologically based pharmacokinetic models are effective support for pediatric drug development

K Wang, K Jiang, X Wei, Y Li, T Wang, Y Song - AAPS PharmSciTech, 2021 - Springer
Pediatric drug development faces many difficulties. Traditionally, pediatric drug doses are
simply calculated linearly based on the body weight, age, and body surface area of adults …

Feasibility of a pragmatic PBPK modeling approach: towards model-informed dosing in pediatric clinical care

JEM van der Heijden, JJM Freriksen… - Clinical …, 2022 - Springer
Abstract Background and Objective More than half of all drugs are still prescribed off-label to
children. Pharmacokinetic (PK) data are needed to support off-label dosing, however for …

First‐pass CYP3A‐mediated metabolism of midazolam in the gut wall and liver in preterm neonates

JM Brussee, H Yu, EHJ Krekels… - CPT …, 2018 - Wiley Online Library
To predict first‐pass and systemic cytochrome P450 (CYP) 3A‐mediated metabolism of
midazolam in preterm neonates, a physiological population pharmacokinetic model was …

Prediction of drug disposition in infants and children by means of physiologically based pharmacokinetic (PBPK) modelling: theophylline and midazolam as model …

S Björkman - British journal of clinical pharmacology, 2005 - Wiley Online Library
Aims To create a general physiologically based pharmacokinetic (PBPK) model for drug
disposition in infants and children, covering the age range from birth to adulthood, and to …

Model-dependent pharmacokinetic analysis of enalapril administered to healthy adult volunteers using orodispersible minitablets for use in pediatrics

M Faisal, W Cawello, BB Burckhardt… - Drug Design …, 2019 - Taylor & Francis
Introduction Comparative pharmacokinetic (PK) data analysis of drugs administered using
developed child-appropriate and market authorized dosage formulation is sparse and is …