3D cell culture models: Drug pharmacokinetics, safety assessment, and regulatory consideration
Nonclinical testing has served as a foundation for evaluating potential risks and
effectiveness of investigational new drugs in humans. However, the current two‐dimensional …
effectiveness of investigational new drugs in humans. However, the current two‐dimensional …
Kidney-based in vitro models for drug-induced toxicity testing
The kidney is frequently involved in adverse effects caused by exposure to foreign
compounds, including drugs. An early prediction of those effects is crucial for allowing novel …
compounds, including drugs. An early prediction of those effects is crucial for allowing novel …
Membrane transporters in drug development and as determinants of precision medicine
A Galetin, KLR Brouwer, D Tweedie… - Nature Reviews Drug …, 2024 - nature.com
The effect of membrane transporters on drug disposition, efficacy and safety is now well
recognized. Since the initial publication from the International Transporter Consortium …
recognized. Since the initial publication from the International Transporter Consortium …
Clinical implications of altered drug transporter abundance/function and PBPK modeling in specific populations: an ITC perspective
The role of membrane transporters on pharmacokinetics (PKs), drug–drug interactions
(DDIs), pharmacodynamics (PDs), and toxicity of drugs has been broadly recognized …
(DDIs), pharmacodynamics (PDs), and toxicity of drugs has been broadly recognized …
New approach methodologies (NAMs) for human-relevant biokinetics predictions: Meeting the paradigm shift in toxicology towards an animal-free chemical risk …
For almost fifteen years, the availability and regulatory acceptance of new approach
methodologies (NAMs) to assess the absorption, distribution, metabolism and excretion …
methodologies (NAMs) to assess the absorption, distribution, metabolism and excretion …
Plasma protein-mediated uptake and contradictions to the free drug hypothesis: a critical review
JA Schulz, DM Stresser, JC Kalvass - Drug metabolism reviews, 2023 - Taylor & Francis
According to the free drug hypothesis (FDH), only free, unbound drug is available to interact
with biological targets. This hypothesis is the fundamental principle that continues to explain …
with biological targets. This hypothesis is the fundamental principle that continues to explain …
New and emerging research on solute carrier and ATP binding cassette transporters in drug discovery and development: outlook from the international transporter …
Enabled by a plethora of new technologies, research in membrane transporters has
exploded in the past decade. The goal of this state‐of‐the‐art article is to describe recent …
exploded in the past decade. The goal of this state‐of‐the‐art article is to describe recent …
Kidney organoid and microphysiological kidney chip models to accelerate drug development and reduce animal testing
Kidneys are critical for the elimination of many drugs and metabolites via the urine, filtering
waste and maintaining proper fluid and electrolyte balance. Emerging technologies …
waste and maintaining proper fluid and electrolyte balance. Emerging technologies …
Protein-bound uremic toxins in hemodialysis patients relate to residual kidney function, are not influenced by convective transport, and do not relate to outcome
MK van Gelder, IR Middel, RWM Vernooij, ML Bots… - Toxins, 2020 - mdpi.com
Protein-bound uremic toxins (PBUTs) are predominantly excreted by renal tubular secretion
and hardly removed by traditional hemodialysis (HD). Accumulation of PBUTs is proposed to …
and hardly removed by traditional hemodialysis (HD). Accumulation of PBUTs is proposed to …
Development of 4‐Pyridoxic Acid PBPK Model to Support Biomarker‐Informed Evaluation of OAT1/3 Inhibition and Effect of Chronic Kidney Disease
SPF Tan, ME Willemin, J Snoeys… - Clinical …, 2023 - Wiley Online Library
Monitoring endogenous biomarkers is increasingly used to evaluate transporter‐mediated
drug–drug interactions (DDIs) in early drug development and may be applied to elucidate …
drug–drug interactions (DDIs) in early drug development and may be applied to elucidate …