Maximizing the Impact of Microphysiological Systems with in Vitro–in Vivo Translation [PDF]
Microphysiological systems (MPS) hold promise for improving therapeutic drug approval rates by providing more physiological, human-based, in vitro assays for preclinical drug development activities compared to traditional in vitro and animal models. Here,
Cirit, Murat, Stokes, Cynthia L.
core +1 more source
Background Information on mitoxantrone pharmacokinetics in children is lacking and reduced dosing regimens applied to infants are supported by limited scientific rationale. The current study characterized mitoxantrone pharmacokinetics in a childhood acute myeloid leukaemia patient population and provides a data‐informed assessment of dosing.
Andrew M. Brandon +13 more
wiley +1 more source
The Many Flavors of Model‐Based Meta‐Analysis: Part I—Introduction and Landmark Data
Meta‐analysis is an increasingly important aspect of drug development as companies look to benchmark their own compounds with the competition. There is scope to carry out a wide range of analyses addressing key research questions from preclinical through
M Boucher, M Bennetts
doaj +1 more source
Integration of Genome Scale Metabolic Networks and gene regulation of metabolic enzymes with Physiologically Based Pharmacokinetics [PDF]
The scope of Physiologically Based Pharmacokinetic (PBPK) modelling can be expanded by assimilation of the mechanistic models of intracellular processes from Systems Biology field.
Al Olama +51 more
core +2 more sources
Intravenous lanadelumab for the treatment of moderately ill COVID‐19 patients
Aims Kallikrein‐kinin system (KKS) dysregulation is hypothesized to play a pathogenetic role in COVID‐19‐associated pulmonary oedema. To investigate the efficacy and safety of intravenous lanadelumab, a monoclonal antibody that inhibits plasma kallikrein, in COVID‐19, we conducted a phase 2, open‐label, randomized‐controlled, proof‐of‐concept ...
Job J. Engel +12 more
wiley +1 more source
A Multiple Imputation Workflow for Handling Missing Covariate Data in Pharmacometrics Modeling
Covariate missingness is a prevalent issue in pharmacometrics modeling. Incorrect handling of missing covariates can lead to biased parameter estimates, adversely affecting clinical practice and drug development dosing decisions.
My‐Luong Vuong +2 more
doaj +1 more source
Effective Visual Communication for the Quantitative Scientist
Effective visual communication is a core competency for pharmacometricians, statisticians, and, more generally, any quantitative scientist. It is essential in every step of a quantitative workflow, from scoping to execution and communicating results and ...
Marc Vandemeulebroecke +3 more
doaj +1 more source
Concentration‐QTc Modeling of Ozanimod’s Major Active Metabolites in Adult Healthy Subjects
Ozanimod, approved by regulatory agencies in multiple countries for the treatment of adults with relapsing multiple sclerosis, is a sphingosine 1‐phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P receptor subtypes 1 ...
Emily Briggs +4 more
doaj +1 more source
The status of pharmacometrics in pregnancy: highlights from the 3rd American conference on pharmacometrics [PDF]
Physiological changes during pregnancy may alter drug pharmacokinetics. Therefore, mechanistic understanding of these changes and, ultimately, clinical studies in pregnant women are necessary to determine if and how dosing regimens should be adjusted.
Hasselt, J.G.C. van +5 more
openaire +3 more sources
Aims The repurposed use of favipiravir in COVID‐19 has been reported to have limited clinical efficacy, yet it has been widely used in some countries. Favipiravir causes mutagenesis in RNA viruses, and it is currently unknown whether it may have a measurable effect on the virus in humans.
Akosua A. Agyeman +9 more
wiley +1 more source

