Toxicology studies
Preclinical toxicology studies look at the adverse effects of test articles (i.e. drugs, toxins, agents) on naïve subjects, and are required by the US Food and Drug Administration, prior to clinical evaluation.
While commonly cardiovascular in nature, adverse effects may present respiratory or neurological challenges to an organism as well.
emka TECHNOLOGIES solutions are specifically designed to help researchers during general toxicology studies, and especially in vivo GLP repeat-dose cardiotoxicity studies.
Description
Our digital solutions allow for wireless, paperless recordings, combined with automated analysis.
Options including GLP compliance and SEND validated exports were designed to shorten your time to reporting.
studyDESIGNER
A smooth transition from paper to digital
Simplify your GLP and non-GLP studies using studyDESIGNER to manage data acquisition, data analysis, and reporting for your toxicology studies. Our modular platform builds and organizes the study with fully integrated data management, workflow guidance, and automation for researchers at each level involved from technicians to study directors.
The automated post-processing shortens time to reporting. Minimal user interaction is required, and built-in audit-trail and electronic signature capabilities ensure data integrity and accountability.
Read more about studyDESIGNER’s modules :
- IOX software, Acquisition and signal monitoring with real-time analysis
- ecgAUTO analysis, Quantitative and qualitative in-depth analysis
Related hardware
emkaPACK4G, wireless telemetry system for large animals
Our non-invasive design eliminates the use of anesthesia or surgery in large animals.
For snapshot ECG recordings, it is used as a mobile system where the receiver and PC can be wheeled between rooms, for maximum efficiency and flexibility when designing your studies.
Repeat-dose toxicity studies can also be carried out in large animals with external (jacketed) telemeters, to provide a functional assessment of heart rhythm, conduction, repolarization and morphology.
Jacketed telemetry is often considered more sensitive and reproducible than traditional “snapshot” recordings in restrained animals, which are the mainstay of cardiovascular toxicity studies owing to their cost-effectiveness and highly valuable reference data.
Easily equip a subject in minutes with our emkaPACK4G transmitter capable of acquiring up to 9-lead ECG, blood pressure (NIBP cuff), respiration frequency (1 or 2 RIP* belts), temperature, and postural activity data.
Combine this non-invasive system with easyTEL+ implantable telemetry for seamless integration of invasive endpoints (i.e., minimally invasive blood pressure, ECG, core temperature, activity). All systems allow for group-housed subjects.
*Respiratory inductance plethysmography
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easyTEL+, fully implantable telemetry system for rodents to large animals
Implanted telemetry remains the gold standard for toxicology studies.
Our M series implants were designed with toxicology studies in mind.
The implant is light and small with 2F or 4.5F pressure catheters and is intended for subcutaneous placement in small primates or other large animal models used in toxicology for acquisition of minimally invasive blood pressure, ECG, temperature, and activity.
ECG leads come with solid tip for intravascular ECG.
Reduce human and subject interaction with remote control of implant state (on/off). Up to 32 subjects can be group-housed with no cross talk. Implants can be wirelessly programmed (i.e. sampling rate, transmission frequency, etc.) before or after implantation.
Stand-alone or used in combination with emkaPACK4G, this system is compact and mobile, requiring only a single ethernet cable connection between the receiver and acquisition PC.
Designed to save you time and money, our implants are priced for single use, eliminating the need for refurbishment and associated logistics.
Related products
Related publications
Justification for species selection for pharmaceutical toxicity studies
Helen Prior et al, Toxicology Research. 2020
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
