Safety Pharmacology

GLP Regulatory and Non-GLP Discovery Pharmacology Testing

Safety Pharmacology

Safety Pharmacology is an essential element of most small-molecule development programs and accompanies the general toxicology for IND filings. At Frontage, we provide an incorporated approach to GLP regulatory safety pharmacology and early non-GLP discovery pharmacology testing performed according to ICH S7A and S7B compliance from research and development to IND submission. Regardless of the approach, the molecule, or the therapeutic indication, Frontage can support your Safety Pharmacology services needs.

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We offer a core battery of studies for in vitro & 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 assessment either as stand-alone or as an embedded endpoint in the general toxicology study.

In-Vivo CNS (Irwin, 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 also Available

In-Vivo CV

  • Assay Consists of Evaluation of Cardiovascular Effects via Implanted Telemetry
    •  Blood Pressure
  • Systolic, Diastolic, Mean Arterial Blood Pressure
    • Heart Rate
    • Qualitative Assessment of Electrocardiographic Data by DVM,
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    • 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.