Preclinical Electrophysiology Consulting, LLC
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Mattapoisett, Massachusetts, US
Preclinical Electrophysiology Consulting provides professional scientific services in support of preclinical drug safety, with a focus on electrophysiology, seizure liability derisking and CNS drug safety. We partner with pharmaceutical companies and CROs, providing services tailored for each sector.
Recent Publications
Detailed, expert electroencephalography (EEG) study setup and analyses
Assessment of seizure potential and detection of premonitory signs of seizure
Discovery EEG screening setup and analyses
Assistance in setting up screening capabilities at your facility
Video-telemetry data analysis capabilities with multiple preclinical collection systems (DSI, EMKA, Biopac,etc.)
Custom automated detection algorithms for screening are available
Expertise with multiple preclinical species
Clinical EEG experience
Model development and surgery assessments
Quantitative electroencephalography (qEEG)
Polysomnography and EEG Sleep Scoring
Pharmaco-sleep investigates the effects of drugs on the central nervous system and sleep-wake cycles.
Sleep/wake cycle detection (sleep scoring or polysomnography/PSG) is adapted after guidelines outlined in "The AASM Manual for the Scoring of Sleep and Associated Events" published by the American Academy of Sleep Medicine, and is performed using spectral analyses/qEEG specific to preclinical models.
Seizure Liability
EEG assessments of seizure potential and detection of premonitory signs of seizure in small and large animals
Telemetry and external EEG scoring in small and large animals.
On-site electrophysiological assessments of ocular toxicity
Safety Pharmacology outsourcing and monitoring services
Best-fit CRO or vendor selection
Facilities and capabilities audits
Technical audits
Establishing preferred vendor contracts and capabilities
In-depth assessments of data collection systems
GLP compliance
Study monitoring
Study design
On-site monitoring
Adherence to protocols, regulatory guidance, and timelines
Data management and QC
Statistics and data interpretation
Report writing and review
ICH S7A Core Battery and Supplemental Studies
The core battery of safety pharmacology studies is required for IND-enabling programs in order to assess the acute and potentially life-threatening risks of novel pharmaceuticals.
Cardiovascular System
Blood pressure, heart rate, electrocardiograms (ECGs), left ventricular pressure
Dual pressure/contractility
Respiratory System
Respiratory rate and volume in small and large animals
Central Nervous System (CNS)
Functional observation battery (FOB), modified Irwin screen, body temperature, neurological evaluations
Integrated studies
Pharmacology & Toxicology Services
Experimental Design Services
Project Management & Consulting Services
Polysomnography study design and Sleep Scoring
Pharmaco-sleep investigates the effects of drugs on the central nervous system and sleep-wake cycles.
Sleep/wake cycle detection (sleep scoring or polysomnography/PSG) is adapted after guidelines outlined in "The AASM Manual for the Scoring of Sleep and Associated Events" published by the American Academy of Sleep Medicine, and is performed using spectral analyses/qEEG specific to preclinical models.
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