ICH S7A & S7B Guidelines-Compliant Safety Pharmacology

Understanding and migrating the potential risks your program faces are crucial to a successful IND submission. Access to an integrated scientific network, spanning drug discovery and preclinical development, can provide insight into potential risks earlier in development.

Our comprehensive, global and harmonized safety pharmacology program complies with International Conference on Harmonisation (ICH) Guidelines (S7A, S7B) and provides the expert interpretations needed to advance your program successfully.

Charles River scientists are active within the international community and are innovating the assays and tools needed to further the translation of preclinical data to clinical outcomes. Our integrated in vitro and in vivo expertise provides a comprehensive approach for de-risking compounds across organ system aiding in effective decision-making in early preclinical development.

  • ICH CORE BATTERY TESTS

    The core battery of safety pharmacology studies should be included in small molecule IND-enabling programs to assess the acute and potentially life-threatening risks of novel pharmaceuticals for human use.

    • Cardiovascular System
      Blood pressure, heart rate, electrocardiograms (ECGs), ventricular pressure and pulmonary, and echocardiography
    • Respiratory System
      Respiratory rate, hemoglobin oxygen saturation, and tidal and minute volumes
    • Central Nervous System (CNS)
      Functional observation battery (FOB), modified Irwin screen, body temperature, and large animal neurological evaluations
    • In Vitro Electrophysiology
      Cloned human potassium channels (hERG)
  • SUPPLEMENTAL STUDIES

    Second-tier studies can be used to develop a greater understanding of mechanistic effects on vital functions, and evaluate potential adverse effects on other organ systems such as renal and gastrointestinal systems.

    • Tier II Assessments
      Cardiovascular system, cardiac output/arterial flow, vascular/peripheral resistance, and central nervous system (CNS) and respiratory system assessments
    • Respiratory
      Lung resistance and plethysmography
    • CNS
      Quantitative motor performance, CNS electrophysiology (EEG), and higher order neurofunctional endpoints
    • Renal/Urinary
      Renal function and general clinical chemistry
    • Gastrointestinal
      Motility and function
    • In Vitro Electrophysiology
      Anticipated CiPA battery

Upcoming Event