Results 81 to 90 of about 3,220 (195)

Quantitative Systems Toxicology Modeling with DILIsym to Support Phase 3 Dose Selection for Fezolinetant

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
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]

open access: yes, 2000
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

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
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

open access: yesADMET and DMPK, 2019
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

The Use of a Physiologically Based Pharmacokinetic Modelling in a “Full-Chain” Exposure Assessment Framework: A Case Study on Urban and Industrial Pollution in Northern Italy

open access: yesAtmosphere, 2020
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

Toward the harmonization of bioequivalence guidelines in Europe: Commentary on the state of the art and future priorities under ICH M13A for immediate‐release oral forms

open access: yes
British Journal of Clinical Pharmacology, EarlyView.
Domenico Nocera   +7 more
wiley   +1 more source

Maternal‐to‐Infant Transfer of Medications for Type 2 Diabetes Mellitus Via Breastmilk: A Systematic Review of Available Evidence and Clinical Guidelines

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
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

Advancing Maternal Health with Long‐Acting Therapeutics: Priorities, Efficacy and Safety Considerations, and Emerging Technologies

open access: yesClinical Pharmacology &Therapeutics, EarlyView.
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 models for systemic disposition of protein therapeutics in rabbits

open access: yesFrontiers in Pharmacology
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]

open access: yes, 2009
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

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