Innovative organotypic in vitro models for safety assessment: aligning with regulatory requirements and understanding models of the heart, skin, and liver as paradigms

Dermal Xenobiotic Metabolism: A Comparison between Native Human Skin, Four in vitro Skin Test Systems and a Liver System

(2017) Christian Wiegand et al.   SKIN PHARMACOLOGY AND PHYSIOLOGY

State of the art in non-animal approaches for skin sensitization testing: from individual test methods towards testing strategies

(2016) Janine Ezendam et al.   ARCHIVES OF TOXICOLOGY

A multicenter assessment of single-cell models aligned to standard measures of cell health for prediction of acute hepatotoxicity

(2016) Rowena L. Sison-Young et al.   ARCHIVES OF TOXICOLOGY

Post-marketing withdrawal of 462 medicinal products because of adverse drug reactions: a systematic review of the world literature

(2016) Igho J. Onakpoya et al.   BMC Medicine

Novel 3D Culture Systems for Studies of Human Liver Function and Assessments of the Hepatotoxicity of Drugs and Drug Candidates

(2016) Volker M. Lauschke et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Instrumented cardiac microphysiological devices via multimaterial three-dimensional printing

(2016) Johan U. Lind et al.   NATURE MATERIALS

Human induced pluripotent stem cell–derived cardiomyocytes recapitulate the predilection of breast cancer patients to doxorubicin-induced cardiotoxicity

(2016) Paul W Burridge et al.   NATURE MEDICINE

Editor’s Highlight: Modeling Compound-Induced FibrogenesisIn VitroUsing Three-Dimensional Bioprinted Human Liver Tissues

(2016) Leah M. Norona et al.   TOXICOLOGICAL SCIENCES

Cardiac Non-myocyte Cells Show Enhanced Pharmacological Function Suggestive of Contractile Maturity in Stem Cell Derived Cardiomyocyte Microtissues

(2016) Stephanie M. Ravenscroft et al.   TOXICOLOGICAL SCIENCES

Cytotoxicity evaluation using cryopreserved primary human hepatocytes in various culture formats

(2016) Lysiane Richert et al.   TOXICOLOGY LETTERS

In silico toxicology: computational methods for the prediction of chemical toxicity

(2016) Arwa B. Raies et al.   Wiley Interdisciplinary Reviews-Computational Molecular Science

Lessons from the fatal French study BIA-10-2474

(2016) Nicholas Moore   BMJ-British Medical Journal

The Comprehensive in Vitro Proarrhythmia Assay (CiPA) initiative — Update on progress

(2016) Thomas Colatsky et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Lessons from the fatal French study BIA-10-2474

(2016) Nicholas Moore   BMJ-British Medical Journal

Comparison of Liver Cell Models Using the Basel Phenotyping Cocktail

(2016) Benjamin Berger et al.   Frontiers in Pharmacology

Bioprinted 3D Primary Liver Tissues Allow Assessment of Organ-Level Response to Clinical Drug Induced Toxicity In Vitro

(2016) Deborah G. Nguyen et al.   PLoS One

Food for thought … on alternative methods for chemical safety testing

(2016) Thomas Hartung   ALTEX-Alternatives to Animal Experimentation

Characterization of primary human hepatocyte spheroids as a model system for drug-induced liver injury, liver function and disease

(2016) Catherine C. Bell et al.   Scientific Reports

Regulating Chemicals: Law, Science, and the Unbearable Burdens of Regulation

(2015) Ellen K. Silbergeld et al.   Annual Review of Public Health

Physiological, pharmacological and toxicological considerations of drug-induced structural cardiac injury

(2015) M J Cross et al.   BRITISH JOURNAL OF PHARMACOLOGY

Characterisation of porcine dermis scaffolds decellularised using a novel non-enzymatic method for biomedical applications

(2015) KV Greco et al.   JOURNAL OF BIOMATERIALS APPLICATIONS

Timescale analysis of a mathematical model of acetaminophen metabolism and toxicity

(2015) Dennis Reddyhoff et al.   JOURNAL OF THEORETICAL BIOLOGY

Pilot study of a novel vacuum-assisted method for decellularization of tracheae for clinical tissue engineering applications

(2015) P. Lange et al.   Journal of Tissue Engineering and Regenerative Medicine

A four-organ-chip for interconnected long-term co-culture of human intestine, liver, skin and kidney equivalents

(2015) Ilka Maschmeyer et al.   LAB ON A CHIP

Micropatterned coculture of primary human hepatocytes and supportive cells for the study of hepatotropic pathogens

(2015) Sandra March et al.   Nature Protocols

Development of a Full-Thickness Human Skin EquivalentIn VitroModel Derived from TERT-Immortalized Keratinocytes and Fibroblasts

(2015) Christianne M.A. Reijnders et al.   TISSUE ENGINEERING PART A

Comparative Proteomic Characterization of 4 Human Liver-Derived Single Cell Culture Models Reveals Significant Variation in the Capacity for Drug Disposition, Bioactivation, and Detoxication

(2015) Rowena L. C. Sison-Young et al.   TOXICOLOGICAL SCIENCES

MUTZ-3 derived Langerhans cells in human skin equivalents show differential migration and phenotypic plasticity after allergen or irritant exposure

(2015) Ilona J. Kosten et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

An integrated testing strategy for in vitro skin corrosion and irritation assessment using SkinEthic™ Reconstructed Human Epidermis

(2015) Nathalie Alépée et al.   TOXICOLOGY IN VITRO

Human iPSC-based Cardiac Microphysiological System For Drug Screening Applications

(2015) Anurag Mathur et al.   Scientific Reports

The use of skin models in drug development

(2014) Stephanie H. Mathes et al.   ADVANCED DRUG DELIVERY REVIEWS

Three-Dimensional Cell Culture Systems and Their Applications in Drug Discovery and Cell-Based Biosensors

(2014) Rasheena Edmondson et al.   ASSAY AND DRUG DEVELOPMENT TECHNOLOGIES

Can in vitro mammalian cell genotoxicity test results be used to complement positive results in the Ames test and help predict carcinogenic or in vivo genotoxic activity? II. Construction and analysis of a consolidated database

(2014) David Kirkland et al.   MUTATION RESEARCH-GENETIC TOXICOLOGY AND ENVIRONMENTAL MUTAGENESIS

Microfluidic organs-on-chips

(2014) Sangeeta N Bhatia et al.   NATURE BIOTECHNOLOGY

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

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

State-of-the-art of 3D cultures (organs-on-a-chip) in safety testing and pathophysiology

(2014) Natalie Alépée   ALTEX-Alternatives to Animal Experimentation

Clear castable polyurethane elastomer for fabrication of microfluidic devices

(2013) Karel Domansky et al.   LAB ON A CHIP

Simple replica micromolding of biocompatible styrenic elastomers

(2013) Mark D. Borysiak et al.   LAB ON A CHIP

Phase II and Phase III attrition rates 2011–2012

(2013) John Arrowsmith et al.   NATURE REVIEWS DRUG DISCOVERY

Phenotypic Profiling of Structural Cardiotoxins In Vitro Reveals Dependency on Multiple Mechanisms of Toxicity

(2013) Amy Pointon et al.   TOXICOLOGICAL SCIENCES

A long-term three dimensional liver co-culture system for improved prediction of clinically relevant drug-induced hepatotoxicity

(2013) Radina Kostadinova et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

An epidermal equivalent assay for identification and ranking potency of contact sensitizers

(2013) Susan Gibbs et al.   TOXICOLOGY AND APPLIED PHARMACOLOGY

Synthetic 3D multicellular systems for drug development

(2012) Markus Rimann et al.   CURRENT OPINION IN BIOTECHNOLOGY

Human gut-on-a-chip inhabited by microbial flora that experiences intestinal peristalsis-like motions and flow

(2012) Hyun Jung Kim et al.   LAB ON A CHIP

Novel in vitro and mathematical models for the prediction of chemical toxicity

(2012) Dominic P. Williams et al.   Toxicology Research

Assessment of Compound Hepatotoxicity Using Human Plateable Cryopreserved Hepatocytes in a 1536-Well-Plate Format

(2011) Timothy A. Moeller et al.   ASSAY AND DRUG DEVELOPMENT TECHNOLOGIES

How can we improve our understanding of cardiovascular safety liabilities to develop safer medicines?

(2011) HG Laverty et al.   BRITISH JOURNAL OF PHARMACOLOGY

The European Medicines Agency: An Overview of Its Mission, Responsibilities, and Recent Initiatives in Cancer Drug Regulation

(2011) Francesco Pignatti et al.   CLINICAL CANCER RESEARCH

Analytical pharmacology: the impact of numbers on pharmacology

(2011) Terry Kenakin et al.   TRENDS IN PHARMACOLOGICAL SCIENCES

Information Needed to Conduct First-in-Human Oncology Trials in the United States: A View from a Former FDA Medical Reviewer

(2010) A. M. Senderowicz   CLINICAL CANCER RESEARCH

The future of toxicity testing: a focus on in vitro methods using a quantitative high-throughput screening platform

(2010) Sunita J. Shukla et al.   DRUG DISCOVERY TODAY

Primary Endothelial Damage Is the Mechanism of Cardiotoxicity of Tubulin-Binding Drugs

(2010) Igor Mikaelian et al.   TOXICOLOGICAL SCIENCES

The utility of the minipig as an animal model in regulatory toxicology

(2010) Gerd Bode et al.   JOURNAL OF PHARMACOLOGICAL AND TOXICOLOGICAL METHODS

Integrated risk assessment and predictive value to humans of non-clinical repolarization assays

(2009) Robert M Wallis   BRITISH JOURNAL OF PHARMACOLOGY

Cardiac Fibroblast

(2009) Colby A. Souders et al.   CIRCULATION RESEARCH

Successful validation of in vitro methods in toxicology by ZEBET, the National Centre for Alternatives in Germany at the BfR (Federal Institute for Risk Assessment)

(2008) Horst Spielmann et al.   EXPERIMENTAL AND TOXICOLOGIC PATHOLOGY

Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma

(2008) Hans-Georg Eichler et al.   NATURE REVIEWS DRUG DISCOVERY