Safety Pharmacology

ICH S7A and S7B guidelines for the conduct of safety pharmacology evaluations recommend a core battery of studies on three vital organ systems (cardiovascular, respiratory and central nervous system) to assess the potential risks of novel pharmaceuticals for human use.

Toxi-Coop is capable to perform the studies required in ICH core battery that contains the following measurements  after single or repeated exposure:

 

Cardiovascular system

Telemetric measurement on dogs or using EMKA ECGTunnel measuring system in conscious rats

• Blood pressure
• Heart rate
• Electrocardiograms (ECGs)
• New electrophysiology testing method on Zebrafish
   (ECG, QT-prolongation with small amount of the compound)

Respiratory system

• Respiratory rate
• Tidal volume (plethysmograph measurement, EMKA system)

Central nervous system (CNS)

• Functional observation battery (FOB)
• Modified Irwin system
• Motor activity measurement with TSE LABMASTER
• Body temperature