Preclinical toxicology investigates the adverse effects of test articles (e.g. drugs, toxins, and other agents) on various model systems to evaluate clinical risk. Toxicology studies are regulated by the US Food and Drug Administration (FDA) to ensure the safety of the population.
Preclinical toxicology integrates many disciplines to investigate a compound’s safety profile, including genotoxicity, mutagenicity, repeat-dose cardiotoxicity, neurotoxicity, and general toxicology.
emka TECHNOLOGIES toxicology solutions cover a wide range of experimental needs for exploratory and GLP toxicology programs based on in vitro, ex vivo and in vivo models.
A smooth transition from paper to digital
studyDESIGNER simplifies GLP and non-GLP studies by managing data acquisition, data analysis, and reporting during toxicology studies. studyDESIGNER’s modular platform builds and organizes the study with fully integrated data management, workflow guidance, and automation at each stage of the experimental process.
Automated post-processing capabilities shorten time to reporting. Built-in audit-trail and electronic signature capabilities ensure data integrity and accountability with minimal user interaction.
emkaPACK4G, wireless telemetry system for large animals
emkaPACK4G non-invasive external telemetry eliminates the need for anaesthesia and surgery in large animal studies, while achieving high-quality translational physiological outcomes. The external transmitter is highly versatile, and can be configured in a “jacketed telemetry” or a “snapshot ECG” fashion.
In a jacketed telemetry study, large animals (canine, primate, swine, sheep, other) are equipped with custom-designed clothing and instrumented with the emkaPACK4G transmitter, which wirelessly transmits physiological signals from the ambulatory subjects.
Jacketed telemetry is often considered more sensitive and reproducible than traditional “snapshot” recordings in restrained animals.
Snapshot-ECG recordings are the mainstay of cardiovascular toxicity studies owing to their cost-effectiveness and vast amount of reference data. The emkaPACK4G can be configured in a mobile snapshot ECG recording system, where the receiver and PC are wheeled into the subject room for maximum efficiency and flexibility.
The emkaPACK4G can simultaneously acquire up to 9-lead ECG, blood pressure (NIBP cuff), respiration frequency (1 or 2 Respiratory Impedance plethysmography [RIP*] belts), temperature, and postural activity data. It provides a comprehensive assessment of heart rhythm, conduction, repolarization and morphology in repeat-dose cardiovascular toxicity studies.
When studies require additional invasive endpoints (e.g. blood pressure), the emkaPACK4G can be augmented with minimally invasive easyTEL+ implants.
*Respiratory inductance plethysmography
easyTEL+, fully implantable telemetry system for rodents to large animals
Implanted telemetry remains the gold standard for toxicology studies in terms of signal quality and data coverage.
emka’s M series is uniquely adapted to toxicology studies. The implant is small and light, with 2F or 4.5F pressure catheters. It is intended for subcutaneous placement in small primates or other large animal models for the acquisition of minimally invasive blood pressure, ECG, temperature, and activity signals. ECG leads come with solid tip for intravascular ECG.
Its key benefits include:
- Superior data quality by reducing human and subject interaction with remote control of implant state (on/off).
- Scalability – up to 32 subjects can be group-housed with no cross talk.
- Flexibility – implants can be wirelessly programmed (i.e. sampling rate, transmission frequency, etc.) before or after implantation.
- Cost-efficient – emka’s implants are priced for single use, eliminating the need for refurbishment and associated logistics to save time and money.
The easyTEL+ system is compact and mobile. It requires a single Ethernet cable connection between the receiver and acquisition PC. It can be used in a stand-alone fashion or in combination with the emkaPACK4G.
Implants for large animals
Justification for species selection for pharmaceutical toxicity studies
Helen Prior et al, Toxicology Research. 2020
A Proof-of-Concept Evaluation of JTPc and Tp-Tec as Proarrhythmia Biomarkers in Preclinical Species: A Retrospective Analysis by an HESI-Sponsored Consortium
Emmanuel Boulay et al, International Journal of Toxicology 2019
Toxicological testing of allogeneic secretome derived from peripheral mononuclear cells (APOSEC): a novel cell-free therapeutic agent in skin disease
SilvioWuschko et al, Scientific Reportsvolume 9, Article number: 5598 (2019)
Women's Cardiovascular Risk from PM Exposure: A Laboratory-based Toxicology Study Using a Sensitive Animal Model
Michael T. Kleinman et al, Report from 2020.
Use of a non-invasive telemetry system (EMKA) for functional cardiovascular endpoints in toxicology studies
Derek Hunter et al, 2003
Oral repeated-dose toxicity studies of BIA 10–2474 in cynomolgus monkeys
Klaus Weber et al, Regulatory Toxicology and Pharmacology, 2019