Safety Pharmacology
Follow-up and Supplemental Tests

Also defined in the ICH guideline are "follow-up" studies, more in-depth studies on the core battery organ systems.  Follow-up studies become necessary when it is desired to have further understanding of a test article's effects on one or more of the core battery organ systems.

  • hERG trafficking assay
  • Cardiac contractility (LVP)
  • Langendorff Isolated Heart model
  • Purkinje fiber assay
  • Echocardiography

In contrast to the core battery, some organ systems can be transiently disrupted without irreversible harm and are of less concern.  Supplemental studies are sometimes conducted on these less critical organ systems. 

  • Gastrointestinal system
    • gastrointestinal transit time
    • gastric damage
    • gastric secretion (pyloric ligation)
  • Renal system
  • Additional supplementary tests
    • abuse liability testing
    • analgesic assessment
    • bleeding time
    • body temperature
    • motor-in coordination (rotarod)
    • proconvulsant activity
    • sleeping time
Posters

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