Safety pharmacology investigates potential undesirable effects of drugs on physiological functions, to predict safety before bringing to market.
emka TECHNOLOGIES provides complete solutions to meet your GLP or non-GLP Safety Pharmacology needs. Our solutions allow for efficient data collection and analysis, in-line with ICH requirements, spanning in-vivo and ex-vivo applications.
The core battery of tests required per ICH guidelines S7A and S7B includes identification, evaluation, and investigation of the cardiovascular, respiratory, and central nervous systems.
*Video electroencephalography
Our easyTEL+ systems allow simultaneous acquisition of core battery and supplemental physiological measurements.
Transmitters can acquire biopotentials (ECG, EEG, EMG, EOG), blood pressure (arterial, LVP), body temperature, and postural activity from conscious, freely moving mice and rats (200g or more) to large animals.
The easyTEL+RP reusable telemeter acquires up to four low-noise biopotentials (cortical or penetrating EEG, EMG, ECG, EOG) as well as activity from rodents 200g or more. It can also be combined with whole body plethysmography for cardiorespiratory measurements.
In large animals, it collects neurological and activity changes without surgical implantation of the telemeter. Subjects are equipped with an external transmitter housed in a jacket or a helmet with surface leads paced on the scalp.
Physiological endpoints can be acquired during behavioral testing (i.e. Elevated Plus Maze, Tail Suspension Test, Barnes Maze). Systems can be synchronized with video for vEEG studies.
emkaPACK5 jacketed telemetry monitors physiological parameters required in the core battery of tests per ICH guidelines S7A and S7B, and is in line with the 3Rs* principles.
These include but are not limited to ECG, non-invasive blood pressure (i.e. tail cuff), respiratory endpoints (see below), temperature (i.e. skin or rectal), and activity from conscious subjects.
Invasive measurements such as arterial and/or left ventricular blood pressure, core body temperature or EEG are available as well using easyTEL+ implants that are synchronized with emkaPACK non-invasive endpoints.
*Replacement, Reduction, Refinement
RIP bands (Respiratory Inductance Plethysmography) allow for measurement of respiratory endpoints non-invasively in large animals.
While ecgAUTO utilizes pioneering shape recognition to analyze large data sets of ECGs and detect arrhythmias in minutes, a separate module is available for RIP analysis. However, both endpoints can be acquired at the same time using the emkaPACK5 transmitter.
emkaPACK5 uses up to 2 RIP bands (abdominal and thoracic) to derive tidal volume, minute volume, phase angle, etc. in large animals. The asynchronous movement between abdominal and thoracic breathing can be seen with the use of 2 RIP belts.
Possible endpoints include but are not limited to heart rate, interval analysis (i.e. RR, PR, QT, QRS, QTc), lung volume measurements (i.e. TV, MV, AVo), frequency, and phase angle with the use of ECG leads and RIP bands, respectively.
The non-invasive double chamber plethysmograph is a proven way to study pulmonary function in restrained, conscious animals. This technique has become the current industry standard as subjects are spontaneously breathing and evade any effects of anesthesia or other external influences. A seal around the restraint creates a distinction between the nasal and thoracic cavities, providing true respiratory flow measurements that comply with ICH S7A Guidelines.
Whole Body Plethysmograph chambers are also commonly used to assess pulmonary function in conscious animals. The use of both techniques as part of the “core battery” tests provide useful and reliable information on pulmonary mechanics in safety pharmacology.
During the 2023 Safety Pharmacology Society (SPS) Conference in Brussels, Dr. Dany Salvail (IPST, QC, Canada) explained how experienced pharmacologists rely on alternate models combined with sophisticated measurement techniques that go well beyond the ICH guidelines to help sponsors truly understand and quantify liabilities associated with their lead compounds early on.
Read the summary of Dr Salvail’s talk below:
In a recent survey1, Simon Authier et al confirms that “The most frequently observed drug mediated effects included an increased heart rate, increased arterial blood pressure, hERG (IKr) block, decreased arterial blood pressure, decreased heart rate, QTc prolongation, and changes in body temperature”.
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