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:
Ø On rats:
– Blood pressure
– Heart rate
– Electrocardiogram (ECG)
On rats:
– Blood pressure
– Heart rate
– Electrocardiogram (ECG)
On fish:
– New electrophysiology testing method om Zebrafish (ECG, QT-prolongation with small amount of compound)
On dogs:
– Telemetric blood pressure, heart rate and ECG recording
Respiratory system:
Ø On rats:
– Respiratory frequency, tidal volume, peak inspiratory and expiratory flow, peak inspiratory and expiratory time, relaxation time, minute colume, Penh
On rats:
– Respiratory frequency, tidal volume, peak inspiratory and expiratory flow, peak inspiratory and expiratory time, relaxation time, minute colume, Penh
Central nervous system:
Ø On rats:
– functional observation battery (FOB)
– Modified Irwin test
– Motor activity measurement
– Rotarod
On rats:
– functional observation battery (FOB)
– Modified Irwin test
– Motor activity measurement
– Rotarod
Guidelines and literature:
S7A – S7B Pharmacology Studies: (link: https://www.ich.org/page/safety-guidelines)