Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates

RM Ward, D Benjamin, JS Barrett, K Allegaert… - Pediatric …, 2017 - nature.com
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 …

Clinical pharmacokinetics and pharmacodynamics of febuxostat

B Kamel, GG Graham, KM Williams, KD Pile… - Clinical …, 2017 - Springer
Febuxostat is a xanthine oxidoreductase inhibitor that has been developed to treat chronic
gout. In healthy subjects, the pharmacokinetic parameters of febuxostat after multiple oral …

Parameter estimation in nonlinear mixed effect models using saemix, an R implementation of the SAEM algorithm

E Comets, A Lavenu, M Lavielle - Journal of Statistical Software, 2017 - jstatsoft.org
The saemix package for R provides maximum likelihood estimates of parameters in
nonlinear mixed effect models, using a modern and efficient estimation algorithm, the …

Liraglutide effects in a paediatric (7‐11 y) population with obesity: A randomized, double‐blind, placebo‐controlled, short‐term trial to assess safety, tolerability …

LD Mastrandrea, L Witten, KC Carlsson Petri… - Pediatric …, 2019 - Wiley Online Library
Background Childhood obesity is a major public health concern with limited treatment
options. Objective The aim of this study was to assess safety, tolerability, pharmacokinetics …

[HTML][HTML] The midpoint of cortical thinning between late childhood and early adulthood differs between individuals and brain regions: Evidence from longitudinal …

D Fuhrmann, KS Madsen, LB Johansen, WFC Baaré… - NeuroImage, 2022 - Elsevier
Charting human brain maturation between childhood and adulthood is a fundamental
prerequisite for understanding the rapid biological and psychological changes during …

PopED: an extended, parallelized, nonlinear mixed effects models optimal design tool

J Nyberg, S Ueckert, EA Strömberg, S Hennig… - Computer methods and …, 2012 - Elsevier
Several developments have facilitated the practical application and increased the general
use of optimal design for nonlinear mixed effects models. These developments include new …

Design evaluation and optimisation in multiple response nonlinear mixed effect models: PFIM 3.0

C Bazzoli, S Retout, F Mentré - Computer methods and programs in …, 2010 - Elsevier
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 …

Methods and software tools for design evaluation in population pharmacokinetics–pharmacodynamics studies

J Nyberg, C Bazzoli, K Ogungbenro… - British journal of …, 2015 - Wiley Online Library
Population pharmacokinetic (PK)–pharmacodynamic (PKPD) models are increasingly used
in drug development and in academic research; hence, designing efficient studies is an …

PFIM 4.0, an extended R program for design evaluation and optimization in nonlinear mixed-effect models

C Dumont, G Lestini, H Le Nagard, F Mentré… - Computer methods and …, 2018 - Elsevier
Abstract Background and Objective Nonlinear mixed-effect models (NLMEMs) are
increasingly used for the analysis of longitudinal studies during drug development. When …

Rapid sample size calculations for a defined likelihood ratio test-based power in mixed-effects models

C Vong, M Bergstrand, J Nyberg, MO Karlsson - The AAPS journal, 2012 - Springer
Efficient power calculation methods have previously been suggested for Wald test-based
inference in mixed-effects models but the only available alternative for Likelihood ratio test …