Safety Pharmacology

Safety Pharmacology studies evaluate the risk of adverse or life-threatening organ system effects posed by new pharmaceutical products and are a required and essential part of many IND-enabling drug safety programs. Given their importance, some Sponsors also supplement their early drug development work with exploratory Safety Pharmacology studies to enable critical project go/no-go decisions. Sinclair Research offers Safety Pharmacology scientific and technical expertise through our partnership with CorDynamics to identify and characterize potential functional safety risks throughout the drug development timeline.

Sinclair Research provides:

  • Integrated and standalone in vivo safety pharmacology assessments
  • A consultative, expert approach to the unique needs of each client and compound
  • Experimental designs to evaluate Safety Pharmacology endpoints
  • Flexibility and experience to support the evaluation of specialized endpoints in your Safety Pharmacology study

Our partnership with CorDynamics allows Sinclair to deliver the highest quality Safety Pharmacology data to our Sponsors. The depth of expertise with this partnership is unique in the industry.

ICH S7A & S7B Guidelines

The Sinclair Research Safety Pharmacology team provides a full range of functional testing services. We conduct Safety Pharmacology studies with fully validated systems in accordance with International Conference on Harmonization (ICH) Guidelines (S7A, S7B), and routinely innovate and implement industry best practices.

Core Battery Safety Pharmacology Studies

As stated in ICH S7A, the purpose of the Safety Pharmacology core battery is to investigate the effects of the test substance on vital organ systems. The cardiovascular, respiratory, and central nervous systems are considered the organ systems that comprise the core battery of safety pharmacology studies. Sinclair Research conducts these assessments using state-of-the-art equipment and our partners at CorDynamics support the data interpretation backed by decades of cardiovascular Safety Pharmacology experience over hundreds of projects.

CorDynamics Partnership Overview

CorDynamics specializes in cardiovascular drug discovery, toxicology and safety pharmacology evaluation. Sinclair Research has acquired the GLP Safety Pharmacology business unit from CorDynamics to offer sponsors GLP cardiopulmonary safety pharmacology studies at our site. We have an ongoing partnership with the cardiovascular research experts at CorDynamics to provide our sponsors with review, analysis, and interpretation of the data generated in Safety Pharmacology studies as well as access to a vast library of cardiovascular drug discovery models including heart failure, pulmonary arterial hypertension and atrial fibrillation.

Cardiovascular System

  • Remote telemetry monitoring of hemodynamics and electrocardiography in freely moving animals, including all contemporary models, with calibrated continuous data collection, using appropriate analytical methods for quantitative and qualitative data along with expert interpretation
  • Cardiac and pulmonary hemodynamics, along with advanced electrophysiology also available

Respiratory System

(as part of the cardiovascular study)

  • Rate, volume, and supplemental derived respiratory mechanic parameters
  • Remote, calibrated telemetry monitoring in freely moving animals with continuous data collection

Central Nervous System

  • Functional Observational Battery (FOB) for small animals
  • Veterinary neurological assessments for large animals

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