Drug permeation and metabolism in Mycobacterium tuberculosis: Prioritising local exposure as essential criterion in new TB drug development

L Tanner, P Denti, L Wiesner, DF Warner - IUBMB life, 2018 - Wiley Online Library
Anti‐tuberculosis (TB) drugs possess diverse abilities to penetrate the different host tissues
and cell types in which infecting Mycobacterium tuberculosis bacilli are located during active …

Optimizing drug development in oncology by clinical trial simulation: Why and how?

J Gal, G Milano, JM Ferrero… - Briefings in …, 2018 - academic.oup.com
In therapeutic research, the safety and efficacy of pharmaceutical products are necessarily
tested on humans via clinical trials after an extensive and expensive preclinical …

Gaining mechanistic insight into coproporphyrin I as endogenous biomarker for OATP1B‐mediated drug–drug interactions using population pharmacokinetic …

S Barnett, K Ogungbenro, K Ménochet… - Clinical …, 2018 - Wiley Online Library
This study evaluated coproporphyrin I (CPI) as a selective endogenous biomarker of
OATP1B‐mediated drug–drug interactions (DDIs) relative to clinical probe rosuvastatin …

Preclinical pharmacology of AZD9977: A novel mineralocorticoid receptor modulator separating organ protection from effects on electrolyte excretion

K Bamberg, U Johansson, K Edman… - PLoS …, 2018 - journals.plos.org
Excess mineralocorticoid receptor (MR) activation promotes target organ dysfunction,
vascular injury and fibrosis. MR antagonists like eplerenone are used for treating heart …

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 …

Suboptimal Antituberculosis drug concentrations and outcomes in small and HIV‐Coinfected children in India: recommendations for dose modifications

B Guiastrennec, G Ramachandran… - Clinical …, 2018 - Wiley Online Library
This work aimed to evaluate the once‐daily antituberculosis treatment as recommended by
the new Indian pediatric guidelines. Isoniazid, rifampin, and pyrazinamide concentration …

Population pharmacokinetics and pharmacodynamics of mycophenolic acid using the prospective data in patients undergoing hematopoietic stem cell transplantation

K Yoshimura, I Yano, T Yamamoto… - Bone marrow …, 2018 - nature.com
Mycophenolate mofetil (MMF), a prodrug of mycophenolic acid (MPA), is used to suppress
GvHD in patients undergoing hematopoietic stem cell transplantation (HCT). The purpose of …

Using vaccine Immunostimulation/Immunodynamic modelling methods to inform vaccine dose decision-making

SJ Rhodes, J Guedj, HA Fletcher, T Lindenstrøm… - Npj Vaccines, 2018 - nature.com
Unlike drug dose optimisation, mathematical modelling has not been applied to vaccine
dose finding. We applied a novel Immunostimulation/Immunodynamic mathematical …

Anticoagulant effects of dabigatran in paediatric patients compared with adults: combined data from three paediatric clinical trials

H Maas, S Gropper, F Huang, J Stangier… - Thrombosis and …, 2018 - thieme-connect.com
Background Physiological age-related changes in the haemostatic and coagulation systems
result in differing anticoagulant assay responses to standard anticoagulants. Therefore, we …

Population pharmacodynamic modelling of midazolam induced sedation in terminally ill adult patients

LG Franken, BCM de Winter… - British journal of …, 2018 - Wiley Online Library
Aims Midazolam is the drug of choice for palliative sedation and is titrated to achieve the
desired level of sedation. A previous pharmacokinetic (PK) study showed that variability …