Results 111 to 120 of about 12,447 (257)
Use of Physiologically Based Pharmacokinetic (PBPK) Models in Marine Mammal Toxicology [PDF]
peer reviewedPhysiologically based pharmacokinetic (PBPK) models are mathematical models that are largely based upon the physiological characteristics of the species and the biochemical properties of the chemical of interest. They quantitatively describe
Blust, Ronny +4 more
core
The FDA published guidance on assessing pharmacokinetics (PK) in participants with impaired renal function in 2024. The IQ CPLG Organ Impairment Working Group summarized the industry’s perspective on this guidance by highlighting a few key updates in the 2024 guidance, including: (1) the recommendation of using estimated glomerular filtration rate ...
Yan Jin +13 more
wiley +1 more source
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
Analysis of Regulatory Inhalation Unit Risk Estimates for Cobalt: Comparison to Epidemiological Data
ABSTRACT Several cancer potency estimates have been proposed by regulatory agencies to characterize the dose response of cobalt and/or cobalt compounds. The objective of this research is to investigate whether these proposed cancer potency estimates for certain cobalt substances align with the available epidemiology literature.
Lynne P. Marshall +4 more
wiley +1 more source
Aims To determine breastmilk concentrations of doravirine via PBPK modelling in combination with a clinical lactation study. As women living with HIV are not able to cease antiretroviral therapy during lactation, it is necessary to establish drug transfer into breastmilk to determine exposure of the infant to antiretroviral drugs and potential risk of ...
Lena van der Wekken‐Pas +3 more
wiley +1 more source
Xiaofei Wu, Ziyang Wang, Shupeng Liu, Hongyun Wang Clinical Pharmacology Research Center, Peking Union Medical College Hospital, State Key Laboratory of Complex Severe and Rare Diseases, NMPA Key Laboratory for Clinical Research and Evaluation of Drug ...
Wu X, Wang Z, Liu S, Wang H
doaj
Abstract This Phase 1, open‐label, 2‐part, single‐dose study aimed to investigate the pharmacokinetics, metabolism, and excretion of xevinapant, a small molecule inhibitor of apoptosis proteins (IAPs), in healthy male subjects. Part 1 focused on determining the mass balance recovery, pharmacokinetics, and metabolic profile of [14C]xevinapant following ...
Annick Menetrey +8 more
wiley +1 more source
Adult patients with anaplastic lymphoma kinase positive (ALK+) advanced non–small‐cell lung cancer (NSCLC) are treated with 600 mg alectinib twice daily (BID) as first‐line treatment.
Tamara vanDonge +6 more
doaj +1 more source
Non-equilibrium entangled steady state of two independent two-level systems
We determine and study the steady state of two independent two-level systems weakly coupled to a stationary non-equilibrium environment. Whereas this bipartite state is necessarily uncorrelated if the splitting energies of the two-level systems are ...
A. Peres +24 more
core +2 more sources
Abstract Accurate characterization of time‐varying clearance (CL) is critical during early drug development, as it informs clinical study design and dosing strategies for future trials. However, detecting and modeling time‐varying clearance is challenging due to limited data availability in early clinical development.
Yongjun Hu, Lan Gao, Ronald Kong
wiley +1 more source

