The role of population PK–PD modelling in paediatric clinical research
RFW De Cock, C Piana, EHJ Krekels, M Danhof… - European journal of …, 2011 - Springer
Children differ from adults in their response to drugs. While this may be the result of changes
in dose exposure (pharmacokinetics [PK]) and/or exposure response (pharmacodynamics …
in dose exposure (pharmacokinetics [PK]) and/or exposure response (pharmacodynamics …
Facilitation of drug evaluation in children by population methods and modelling
M Tod, V Jullien, G Pons - Clinical pharmacokinetics, 2008 - Springer
The pharmacokinetics and pharmacodynamics of drugs are different in adult and paediatric
populations, the latter being particularly heterogeneous. These differences in …
populations, the latter being particularly heterogeneous. These differences in …
Basic concepts in population modeling, simulation, and model‐based drug development—part 2: introduction to pharmacokinetic modeling methods
DR Mould, RN Upton - CPT: pharmacometrics & systems …, 2013 - Wiley Online Library
Population pharmacokinetic models are used to describe the time course of drug exposure
in patients and to investigate sources of variability in patient exposure. They can be used to …
in patients and to investigate sources of variability in patient exposure. They can be used to …
Computing normalised prediction distribution errors to evaluate nonlinear mixed-effect models: the npde add-on package for R
Pharmacokinetic/pharmacodynamic data are often analysed using nonlinear mixed-effect
models, and model evaluation should be an important part of the analysis. Recently …
models, and model evaluation should be an important part of the analysis. Recently …
Estimation of population pharmacokinetic parameters of saquinavir in HIV patients with the MONOLIX software
M Lavielle, F Mentré - Journal of pharmacokinetics and …, 2007 - Springer
In nonlinear mixed-effects models, estimation methods based on a linearization of the
likelihood are widely used although they have several methodological drawbacks. Kuhn and …
likelihood are widely used although they have several methodological drawbacks. Kuhn and …
Pharmacokinetics/pharmacodynamics and the stages of drug development: role of modeling and simulation
Pharmacokinetic (PK) and pharmacodynamic (PD) modeling and simulation (M&S) are well-
recognized powerful tools that enable effective implementation of the learn-and-confirm …
recognized powerful tools that enable effective implementation of the learn-and-confirm …
Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates
The study of medications among pediatric patients has increased worldwide since 1997 in
response to new legislation and regulations, but these studies have not yet adequately …
response to new legislation and regulations, but these studies have not yet adequately …
Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0
Nonlinear mixed effect models (NLMEM) with multiple responses are increasingly used in
pharmacometrics, one of the main examples being the joint analysis of the pharmacokinetics …
pharmacometrics, one of the main examples being the joint analysis of the pharmacokinetics …
Advanced methods for dose and regimen finding during drug development: summary of the EMA/EFPIA workshop on dose finding (London 4–5 December 2014)
FT Musuamba, E Manolis, N Holford… - CPT …, 2017 - Wiley Online Library
Inadequate dose selection for confirmatory trials is currently still one of the most challenging
issues in drug development, as illustrated by high rates of late‐stage attritions in clinical …
issues in drug development, as illustrated by high rates of late‐stage attritions in clinical …
[图书][B] Antimicrobial pharmacodynamics in theory and clinical practice
CH Nightingale, PG Ambrose, GL Drusano… - 2007 - books.google.com
Taking readers from the research laboratory to the bedside, this Second Edition compiles
essential information on the pharmacodynamics of all major classes of the antimicrobial …
essential information on the pharmacodynamics of all major classes of the antimicrobial …