[HTML][HTML] Impact of gastrointestinal physiology on drug absorption in special populations––An UNGAP review

C Stillhart, K Vučićević, P Augustijns, AW Basit… - European Journal of …, 2020 - Elsevier
The release and absorption profile of an oral medication is influenced by the
physicochemical properties of the drug and its formulation, as well as by the anatomy and …

Model-informed precision dosing: background, requirements, validation, implementation, and forward trajectory of individualizing drug therapy

AS Darwich, TM Polasek, JK Aronson… - Annual review of …, 2021 - annualreviews.org
Model-informed precision dosing (MIPD) has become synonymous with modern approaches
for individualizing drug therapy, in which the characteristics of each patient are considered …

Scientific and regulatory evaluation of mechanistic in silico drug and disease models in drug development: Building model credibility

FT Musuamba, I Skottheim Rusten… - CPT …, 2021 - Wiley Online Library
The value of in silico methods in drug development and evaluation has been demonstrated
repeatedly and convincingly. While their benefits are now unanimously recognized …

Optimizing mycophenolic acid exposure in kidney transplant recipients: time for target concentration intervention

DK Metz, N Holford, JY Kausman, A Walker… - …, 2019 - journals.lww.com
The immunosuppressive agent mycophenolate is used extensively in kidney transplantation,
yet dosing strategy applied varies markedly from fixed dosing (“one-dose-fits-all”), to …

Can population pharmacokinetics of antibiotics be extrapolated? Implications of external evaluations

Y Cheng, C Wang, Z Li, Y Pan, M Liu, Z Jiao - Clinical pharmacokinetics, 2021 - Springer
Background and objective External evaluation is an important issue in the population
pharmacokinetic analysis of antibiotics. The purpose of this review was to summarize the …

Handling interoccasion variability in model‐based dose individualization using therapeutic drug monitoring data

JA Abrantes, S Jönsson, MO Karlsson… - British journal of …, 2019 - Wiley Online Library
Aims This study aims to assess approaches to handle interoccasion variability (IOV) in a
model‐based therapeutic drug monitoring (TDM) context, using a population …

Efficacy of vancomycin and meropenem in central nervous system infections in children and adults: current update

F Schneider, A Gessner, N El-Najjar - Antibiotics, 2022 - mdpi.com
The current antimicrobial therapy of bacterial infections of the central nervous system (CNS)
in adults and pediatric patients is faced with many pitfalls as the drugs have to reach …

Model‐informed approach supporting drug development and regulatory evaluation for rare diseases

RJ Li, L Ma, F Li, L Li, Y Bi, Y Yuan, Y Li… - The Journal of …, 2022 - Wiley Online Library
A rare disease is defined as a condition affecting fewer than 200 000 people in the United
States by the Orphan Drug Act. For rare diseases, it is challenging to enroll a large number …

Training the next generation of pharmacometric modelers: a multisector perspective

PL Bonate, JS Barrett, S Ait-Oudhia… - … of Pharmacokinetics and …, 2024 - Springer
The current demand for pharmacometricians outmatches the supply provided by academic
institutions and considerable investments are made to develop the competencies of these …

What is the best size predictor for dose in the obese child?

BJ Anderson, NHG Holford - Pediatric Anesthesia, 2017 - Wiley Online Library
Lean body mass is commonly proposed for anesthesia maintenance drug dosing
calculations. However, total body mass used with allometric scaling has been shown to be …