IVIVE: Facilitating the Use of In Vitro Toxicity Data in Risk Assessment and Decision Making

X Chang, YM Tan, DG Allen, S Bell, PC Brown… - Toxics, 2022 - mdpi.com
During the past few decades, the science of toxicology has been undergoing a
transformation from observational to predictive science. New approach methodologies …

[HTML][HTML] Recent advances in the translation of drug metabolism and pharmacokinetics science for drug discovery and development

Y Lai, X Chu, L Di, W Gao, Y Guo, X Liu, C Lu… - … Pharmaceutica Sinica B, 2022 - Elsevier
Drug metabolism and pharmacokinetics (DMPK) is an important branch of pharmaceutical
sciences. The nature of ADME (absorption, distribution, metabolism, excretion) and PK …

Exploration and application of a liver-on-a-chip device in combination with modelling and simulation for quantitative drug metabolism studies

L Docci, N Milani, T Ramp, AA Romeo, P Godoy… - Lab on a Chip, 2022 - pubs.rsc.org
Microphysiological systems (MPS) are complex and more physiologically realistic cellular in
vitro tools that aim to provide more relevant human in vitro data for quantitative prediction of …

Development of a roadmap for action on new approach methodologies in risk assessment

SE Escher, F Partosch, S Konzok… - EFSA Supporting …, 2022 - Wiley Online Library
While whole animal studies have their place in risk assessment of food and feed
components, it is thought that more modern approaches such as human focused new …

Organotypic and microphysiological human tissue models for drug discovery and development—current state-of-the-art and future perspectives

S Youhanna, AM Kemas, L Preiss, Y Zhou… - Pharmacological …, 2022 - ASPET
The number of successful drug development projects has been stagnant for decades
despite major breakthroughs in chemistry, molecular biology, and genetics. Unreliable target …

Recent developments in in vitro and in vivo models for improved translation of preclinical pharmacokinetics and pharmacodynamics data

J Yadav, M El Hassani, J Sodhi… - Drug metabolism …, 2021 - Taylor & Francis
Improved pharmacokinetics/pharmacodynamics (PK/PD) prediction in the early stages of
drug development is essential to inform lead optimization strategies and reduce attrition …

PBPK modeling as a tool for predicting and understanding intestinal metabolism of uridine 5′-Diphospho-glucuronosyltransferase substrates

MB Reddy, MB Bolger, G Fraczkiewicz, L Del Frari… - Pharmaceutics, 2021 - mdpi.com
Uridine 5′-diphospho-glucuronosyltransferases (UGTs) are expressed in the small
intestines, but prediction of first-pass extraction from the related metabolism is not well …

[HTML][HTML] Liver-on-chips for drug discovery and development

V Mehta, G Karnam, V Madgula - Materials Today Bio, 2024 - Elsevier
Recent FDA modernization act 2.0 has led to increasing industrial R&D investment in
advanced in vitro 3D models such as organoids, spheroids, organ-on-chips, 3D bioprinting …

Recent advances in measurement of metabolic clearance, metabolite profile and reaction phenotyping of low clearance compounds

L Di - Expert Opinion on Drug Discovery, 2023 - Taylor & Francis
Introduction Low metabolic clearance is usually a highly desirable property of drug
candidates in order to reduce dose and dosing frequency. However, measurement of low …

Evaluation and Optimization of a Microcavity Plate–Based Human Hepatocyte Spheroid Model for Predicting Clearance of Slowly Metabolized Drug Candidates

DA Kukla, DG Belair… - Drug Metabolism and …, 2024 - dmd.aspetjournals.org
In vitro clearance assays are routinely conducted in drug discovery to predict in vivo
clearance, but low metabolic turnover compounds are often difficult to evaluate. Hepatocyte …