Safety Pharmacology | SRI International

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Safety Pharmacology

SRI’s services meet worldwide standards and regulatory requirements for an IND application. The ICH S7 guidelines on Safety Pharmacology outline recommendations for evaluating the potential for adverse pharmacodynamics and pathophysiological effects on vital functions.

The ICH S7A Core and Supplemental Batteries describe safety assessments of the central nervous system, cardiovascular system, respiratory system, and effects on organ system function.

The ICH S7B guideline recommends a strategy to assess the potential for cardiac safety liability using in vivo and in vitro approaches.

Related Services

ICH S7A Core Battery

  • Central nervous system

  • Cardiovascular system

  • Respiratory system

ICH S7A Supplemental Battery

  • Learning and memory

  • Behavioral pharmacology

  • Ligand-specific and receptor binding and neurochemistry

  • Electroencephalography

  • Drug dependency potential

  • Sleep/circadian rhythm

  • Cardiac output, ventricular contractility, vascular resistance

  • Pulmonary arterial pressure, blood gases, and pH

  • Cardiac biomarkers: B-type natriuretic peptide, troponin I, myoglobin

  • Urinary chemistry profile

  • Gastric motility and function

  • Immune functional profiling—ICHS8

  • Organ-specific characterization and functional profiling

ICH S7B Cardiac Safety and QT Prolongation

  • hERG (human ether-a-go-go-related-gene) assay*

  • APD Purkinje fiber (offered through agreement with ChanTest Corporation)

Projects

Partnering to Advance Therapy for Radiation Exposure

Partnering to Advance Therapy for Radiation Exposure

scientist looking through a microscope

Toxicological Evaluation of Novel Ligands Program

For the National Institute of Mental Health (NIMH), SRI performs preclinical safety and pharmacokinetics studies for brain imaging agents and drugs to treat mental illnesses.