A model-informed preclinical approach for prediction of clinical pharmacodynamic interactions of anti-TB drug combinations

O Clewe, SG Wicha, CP de Vogel… - Journal of …, 2018 - academic.oup.com
Background Identification of pharmacodynamic interactions is not reasonable to carry out in
a clinical setting for many reasons. The aim of this work was to develop a model-informed …

Translational model‐informed approach for selection of tuberculosis drug combination regimens in early clinical development

BO Susanto, SG Wicha, Y Hu… - Clinical …, 2020 - Wiley Online Library
The development of optimal treatment regimens in tuberculosis (TB) remains challenging
due to the need of combination therapy and possibility of pharmacodynamic (PD) …

Comparisons of analysis methods for assessment of pharmacodynamic interactions including design recommendations

C Chen, SG Wicha, R Nordgren, USH Simonsson - The AAPS Journal, 2018 - Springer
Quantitative evaluation of potential pharmacodynamic (PD) interactions is important in
tuberculosis drug development in order to optimize Phase 2b drug selection and ultimately …

Assessing pharmacodynamic interactions in mice using the multistate tuberculosis pharmacometric and general pharmacodynamic interaction models

C Chen, SG Wicha, GJ de Knegt… - CPT …, 2017 - Wiley Online Library
The aim of this study was to investigate pharmacodynamic (PD) interactions in mice infected
with Mycobacterium tuberculosis using population pharmacokinetics (PKs), the Multistate …

In vitro pharmacokinetic/pharmacodynamic models in anti-infective drug development: focus on TB

PK Vaddady, RE Lee, B Meibohm - Future medicinal chemistry, 2010 - Taylor & Francis
For rapid anti-tuberculosis (TB) drug development in vitro pharmacokinetic/
pharmacodynamic (PK/PD) models are useful in evaluating the direct interaction between …

Improved power for TB Phase IIa trials using a model-based pharmacokinetic–pharmacodynamic approach compared with commonly used analysis methods

RJ Svensson, SH Gillespie… - Journal of Antimicrobial …, 2017 - academic.oup.com
Background: The demand for new anti-TB drugs is high, but development programmes are
long and costly. Consequently there is a need for new strategies capable of accelerating this …

Use of multiple pharmacodynamic measures to deconstruct the Nix-TB regimen in a short-course murine model of tuberculosis

MA Lyons, A Obregon-Henao, ME Ramey… - Antimicrobial Agents …, 2024 - Am Soc Microbiol
ABSTRACT A major challenge for tuberculosis (TB) drug development is to prioritize
promising combination regimens from a large and growing number of possibilities. This …

Model-informed drug discovery and development strategy for the rapid development of anti-tuberculosis drug combinations

RC Van Wijk, R Ayoun Alsoud, H Lennernäs… - Applied Sciences, 2020 - mdpi.com
Featured Application Model-informed drug discovery and development (MID3) is proposed
to be applied throughout the preclinical to clinical phases to provide an informative …

The role of the time-kill kinetics assay as part of a preclinical modeling framework for assessing the activity of anti-tuberculosis drugs

HI Bax, IAJM Bakker-Woudenberg, CP de Vogel… - Tuberculosis, 2017 - Elsevier
Novel treatment strategies for tuberculosis are urgently needed. Many different preclinical
models assessing anti-tuberculosis drug activity are available, but it is yet unclear which …

The multistate tuberculosis pharmacometric model: a semi-mechanistic pharmacokinetic-pharmacodynamic model for studying drug effects in an acute tuberculosis …

C Chen, F Ortega, J Rullas, L Alameda… - … of pharmacokinetics and …, 2017 - Springer
Abstract The Multistate Tuberculosis Pharmacometric (MTP) model, a pharmacokinetic-
pharmacodynamic disease model, has been used to describe the effects of rifampicin on …