GLP Regulatory and Non-GLP Discovery Pharmacology Testing
Safety Pharmacology is an essential element of most small-molecule development programs and accompanies the general toxicology for IND filings. The purpose of safety pharmacology studies includes determining adverse effects, assessing and mitigating risks, and projecting a safety margin. At Frontage, we provide an incorporated approach to GLP safety pharmacology for regulatory purposes, and early non-GLP discovery pharmacology testing performed according to ICH S7A and S7B compliance from research and development to IND submission. We provide studies for in vitro safety pharmacology as well as in vivo safety pharmacology. Regardless of the approach, the molecule, or the therapeutic indication, Frontage can support your Safety Pharmacology studies.
We offer a core battery of studies including in vitro and in vivo cardiovascular (CV) testing as well as neuroscience (CNS) and respiratory assessments for your non-clinical programs.
CNS Safety Assessments
At Frontage, we conduct CNS safety assessments either as a stand-alone or as an embedded endpoint in the general toxicology study.
In Vivo CNS (Using a modified Irwin screen, Functional Observational Battery)
- Locomotor activity
- Behavior
- Coordination
- Sensory Motor reflex
- Body temperature
Cardiovascular Safety Assessments
At Frontage, we offer both in vitro and in vivo cardiovascular safety assessment services.
In Vitro CV
- Standard hERG Ion Channel Study
- CiPA-Compliant Version of the Study
- Additional Ion channel Evaluations Cav1.2 and Nav1.5 are also available
In Vivo CV
- Assay Consists of Evaluation of Cardiovascular Effects via Implanted Telemetry [Alternatively, cardiovascular/respiratory function can be evaluated using the Jacketed (non-invasive) DSI Telemetry System]
- Blood Pressure
- Systolic, Diastolic, Mean Arterial Blood Pressure
- Heart Rate
- Qualitative Assessment of Electrocardiographic Data by DVM,
DACVIM veterinarian - Quantitative Assessment of electrocardiogram
- PR Interval, QRS Duration, QT Interval, and Corrected QT
- (QTcV) Interval
- Internal Temperature
Respiratory Safety Assessments
Our Respiratory Safety studies include whole-body plethysmography.
- Tidal Volume
- Minute Volume
- Respiratory Rate
Frontage provides a full suite of safety assessment and toxicology services to guide new therapies from discovery to full drug candidate development support.
Resources To Consider
Safety Pharmacology Services
Importance of Safety Pharmacology in IND Filings
Safety and Toxicology Services Brochure
