Results 81 to 90 of about 3,220 (195)
Fezolinetant is a first‐in‐class, selective, non‐hormonal, neurokinin 3 receptor antagonist that is approved for the treatment of moderate to severe vasomotor symptoms due to menopause. In a phase 2b clinical study (n = 352), nine study participants experienced elevations in serum transaminases exceeding three times the upper limit of normal.
Jace C. Nielsen +11 more
wiley +1 more source
Applications of population approaches in toxicology [PDF]
International audienceMany experimental or observational studies in toxicology are best analysed in a population framework. Recent examples include investigations of the extent and origin of intra-individual variability in toxicity studies, incorporation
Bois, Frédéric Y.
core +5 more sources
PKRxiv: A Best Practice Model for Advancing Pharmacoequity Through Open Pharmacokinetic Data Sharing
Model‐informed drug development is increasingly integrated across the drug development continuum, enabling more efficient, cost‐effective, and targeted trials while reducing reliance on animal studies. Achieving pharmacoequity requires not only equitable access to medicines but also to the data and knowledge that inform drug development and regulatory ...
Shakir Atoyebi +6 more
wiley +1 more source
Building in-house PBPK modelling tools for oral drug administration from literature information
The interest in using physiologically-based pharmacokinetic (PBPK) models as a support to the drug development decision making process has rapidly increased in the last years. These kind of models are examples of the “bottom up” modelling strategy, which
Silvia Grandoni +4 more
doaj +1 more source
Background and goals: The estimate of the internal dose provided by physiologically based pharmacokinetic (PBPK) modelling is a big step forward in the frame of human health risk assessment (HRA) from contaminating sources. The PBPK model included in the
Lorenzo Vaccari +4 more
doaj +1 more source
This review evaluates the available pharmacokinetic data on the plasma‐to‐breastmilk transfer of first‐ and second‐line T2DM drugs against available clinical guideline recommendations. A list of drug therapies for treating T2DM was generated from national and international clinical guidelines.
Katherine Richardson +4 more
wiley +1 more source
Maternal health remains a critical global concern, particularly in underserved populations and in low‐ and middle‐income countries where access to safe and effective therapeutics is limited. Despite the use of medications by most women during pregnancy, the exclusion of pregnant and lactating women from clinical trials has resulted in significant data ...
Rachel K. Scott +7 more
wiley +1 more source
Physiologically based pharmacokinetic (PBPK) modelling is an important tool to predict drug disposition in the body. Rabbits play a pivotal role as a highly valued small animal model, particularly in the field of ocular therapeutics, where they serve as ...
Ravi Kumar Jairam +3 more
doaj +1 more source
Development of a physiologically based kinetic model for 99m-Technetium-labelled carbon nanoparticles inhaled by humans [PDF]
International audienceParticulate air pollution is associated with respiratory and cardiovascular morbidity and mortality. Recent studies investigated whether and to which extent inhaled ultrafine particles are able to translocate into the bloodstream in
Bois, Frédéric Y. +4 more
core +3 more sources

