Preclinical toxicology investigates the adverse effects of test articles (e.g. drugs, toxins, and other agents) on various model systems to evaluate clinical risk.
Preclinical toxicology integrates many disciplines to investigate a compound’s safety profile, including genotoxicity, mutagenicity, repeat-dose cardiotoxicity, neurotoxicity, and general toxicology.
In the United States, toxicology studies are regulated by the US Food and Drug Administration (FDA) to ensure the safety of the population. The FDA requests the nonclinical data from single dose toxicity and repeat-dose toxicity studies to be submitted according to the SEND format (Standard for Exchange of Nonclinical Data).
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, in accordance with the FDA requirements.
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.
Read more about studyDESIGNER’s modules:
Our software modules generate SEND 3.1 compatible tables. The data can easily be exported to .xls, .csv and integrated into third-party solutions by Instem and Xybion to increase productivity in preclinical studies.
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:
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 emkaPACK5.
emkaPACK5 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 emkaPACK5 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 emkaPACK5 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 emkaPACK5 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 emkaPACK5 can be augmented with minimally invasive easyTEL+ implants.
*Respiratory inductance plethysmography
rodentPACK non-invasive external telemetry eliminates the need for anaesthesia and surgery in rats studies, while achieving high-quality translational physiological outcomes. The external transmitter is highly versatile, and can be configured in a “jacketed telemetry” or a “head-out” fashion for neurologic studies.
In a jacketed telemetry study, rats are equipped with custom-designed clothing and instrumented with the rodentPACK transmitter, which wirelessly transmits physiological signals from the ambulatory subjects.
When studies require additional invasive endpoints (e.g. blood pressure), the rodentPACK can be augmented with minimally invasive easyTEL+ implants, using the same hardware configuration.
It cans also be reused for neurological applications, with a head-mounted implantation.
Non-invasive plethysmography techniques such as whole body plethysmography (WBP), double chamber plethysmography (DCP), or head-out plethysmography (HOP) can be used in exploratory toxicology studies to asses the toxicity risk of a candidate drug in conscious animals. This technique provides essential physiological information related to changes in respiratory function measurements such as tidal volume (Vt), respiratory rate (RR) and minute ventilation (MV).
Airway obstruction is one of the leading respiratory difficulties encountered during clinical trials of a drug candidate and although these techniques provide the advantage of assessment of respiratory function measurements, independent of anaesthetic side effects, the drawback is that these techniques do not provide information related to lung mechanics such as airway resistance.
During the 2023 Safety Pharmacology Society (SPS) Conference in Brussels, Dr. Donald Hodges (CBSET, MA, USA) discussed the history, regulatory framework and other factors influencing species selection in IND-enabling studies.
He outlined how proven translational characteristics and historical data are enabling the wider adoption of swine as an alternative to dogs and Non-Human Primates in the context of shortages and rising costs.
Read the summary of Dr Hodges’ talk below:
Save time evaluating emka TECHNOLOGIES equipment by having an Application Specialist conduct a custom literature research.
Researchers will receive an email report showing emka TECHNOLOGIES publications relevant to their specific application research area, along with custom equipment recommendations and commentary.
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