Human biology-based drug safety evaluation: scientific rationale, current status and future challenges

T Cell–Mediated Hypersensitivity Reactions to Drugs

(2015) Rebecca Pavlos et al.   Annual Review of Medicine

A human liver microphysiology platform for investigating physiology, drug safety, and disease models

(2015) Lawrence A Vernetti et al.   EXPERIMENTAL BIOLOGY AND MEDICINE

Treatment of PD-1−/−mice with amodiaquine and anti-CTLA4 leads to liver injury similar to idiosyncratic liver injury in patients

(2015) Imir G. Metushi et al.   HEPATOLOGY

Drug-induced allergic hepatitis develops in mice when myeloid-derived suppressor cells are depleted prior to halothane treatment

(2015) Mala Chakraborty et al.   HEPATOLOGY

An analysis of the attrition of drug candidates from four major pharmaceutical companies

(2015) Michael J. Waring et al.   NATURE REVIEWS DRUG DISCOVERY

Quantification of Drug-Induced Inhibition of Canalicular Cholyl-l-Lysyl-Fluorescein Excretion From Hepatocytes by High Content Cell Imaging

(2015) Jane A. Barber et al.   TOXICOLOGICAL SCIENCES

Reducing attrition through early assessment of drug safety: Highlights from the Society of Medicines Research Symposium, held on March 13th, 2014 - National Heart & Lung Institute, Kensington, London, U.K.

(2015) W. Alderton et al.   DRUGS OF THE FUTURE

A testing strategy to predict risk for drug-induced liver injury in humans using high-content screen assays and the ‘rule-of-two’ model

(2014) Minjun Chen et al.   ARCHIVES OF TOXICOLOGY

Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework

(2014) David Cook et al.   NATURE REVIEWS DRUG DISCOVERY

Drug-Induced Hepatic Steatosis

(2014) Naga Chalasani et al.   SEMINARS IN LIVER DISEASE

Mechanisms of acetaminophen-induced cell death in primary human hepatocytes

(2014) Yuchao Xie et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

Linking physiology to toxicity using DILIsym®, a mechanistic mathematical model of drug-induced liver injury

(2013) Lisl K. M. Shoda et al.   BIOPHARMACEUTICS & DRUG DISPOSITION

Screening Drug-Induced Arrhythmia Using Human Induced Pluripotent Stem Cell-Derived Cardiomyocytes and Low-Impedance Microelectrode Arrays

(2013) E. G. Navarrete et al.   CIRCULATION

The Liver Toxicity Knowledge Base: A Systems Approach to a Complex End Point

(2013) M Chen et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Multiscale modelling approach combining a kinetic model of glutathione metabolism with PBPK models of paracetamol and the potential glutathione-depletion biomarkers ophthalmic acid and 5-oxoproline in humans and rats

(2013) Suzanne Geenen et al.   Integrative Biology

Hybridin silicomodels for drug-induced liver injury using chemical descriptors andin vitrocell-imaging information

(2013) Xiang-Wei Zhu et al.   JOURNAL OF APPLIED TOXICOLOGY

Assessment of gadoxetate DCE-MRI as a biomarker of hepatobiliary transporter inhibition

(2013) Jose L. Ulloa et al.   NMR IN BIOMEDICINE

A Multifactorial Approach to Hepatobiliary Transporter Assessment Enables Improved Therapeutic Compound Development

(2013) Ryan E. Morgan et al.   TOXICOLOGICAL SCIENCES

A Correlation Between the In Vitro Drug Toxicity of Drugs to Cell Lines That Express Human P450s and Their Propensity to Cause Liver Injury in Humans

(2013) Frida Gustafsson et al.   TOXICOLOGICAL SCIENCES

Safety pharmacology — Current and emerging concepts

(2013) Junnat Hamdam et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

Evaluation of the use of imaging parameters for the detection of compound-induced hepatotoxicity in 384-well cultures of HepG2 cells and cryopreserved primary human hepatocytes

(2013) Helen Garside et al.   TOXICOLOGY IN VITRO

Preclinical Strategy to Reduce Clinical Hepatotoxicity Using in Vitro Bioactivation Data for >200 Compounds

(2012) Melanie Z. Sakatis et al.   CHEMICAL RESEARCH IN TOXICOLOGY

In Vitro Approach to Assess the Potential for Risk of Idiosyncratic Adverse Reactions Caused by Candidate Drugs

(2012) Richard A. Thompson et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Frequency of adverse drug reactions in hospitalized patients: a systematic review and meta-analysis

(2012) Ana Miguel et al.   PHARMACOEPIDEMIOLOGY AND DRUG SAFETY

Use of Micropatterned Cocultures to Detect Compounds That Cause Drug-Induced Liver Injury in Humans

(2012) Salman R. Khetani et al.   TOXICOLOGICAL SCIENCES

A high-throughput dual parameter assay for assessing drug-induced mitochondrial dysfunction provides additional predictivity over two established mitochondrial toxicity assays

(2012) James Hynes et al.   TOXICOLOGY IN VITRO

Development of High Content Imaging Methods for Cell Death Detection in Human Pluripotent Stem Cell-Derived Cardiomyocytes

(2012) Maxime Mioulane et al.   Journal of Cardiovascular Translational Research

In vitro models for liver toxicity testing

(2012) Valerie Y. Soldatow et al.   Toxicology Research

Animal models of idiosyncratic drug-induced liver injury—Current status

(2011) Robert A. Roth et al.   CRITICAL REVIEWS IN TOXICOLOGY

Acetaminophen hepatotoxicity and repair: the role of sterile inflammation and innate immunity

(2011) Hartmut Jaeschke et al.   LIVER INTERNATIONAL

Managing the challenge of chemically reactive metabolites in drug development

(2011) B. Kevin Park et al.   NATURE REVIEWS DRUG DISCOVERY

Risk assessment and mitigation strategies for reactive metabolites in drug discovery and development

(2010) Richard A. Thompson et al.   CHEMICO-BIOLOGICAL INTERACTIONS

Deleterious Effects of Reactive Metabolites

(2010) Sabry M. Attia   Oxidative Medicine and Cellular Longevity

Macrophages and Inflammatory Mediators in Chemical Toxicity: A Battle of Forces

(2009) Debra L. Laskin   CHEMICAL RESEARCH IN TOXICOLOGY

An In Vitro Assay to Assess Transporter-Based Cholestatic Hepatotoxicity Using Sandwich-Cultured Rat Hepatocytes

(2009) J. H. Ansede et al.   DRUG METABOLISM AND DISPOSITION

Synergistic drug–cytokine induction of hepatocellular death as an in vitro approach for the study of inflammation-associated idiosyncratic drug hepatotoxicity

(2009) Benjamin D. Cosgrove et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY