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:

–          Blood pressure

–          Heart rate

–          Electrocardiogram (ECG)

–          Blood pressure

–          Heart rate

–          Electrocardiogram (ECG)

–          New electrophysiology testing method om Zebrafish (ECG, QT-prolongation with small amount of compound)

–          Telemetric blood pressure, heart rate and ECG recording

Respiratory system:

–          Respiratory frequency, tidal volume, peak inspiratory and expiratory flow, peak inspiratory and expiratory time, relaxation time, minute colume, Penh

–          Respiratory frequency, tidal volume, peak inspiratory and expiratory flow, peak inspiratory and expiratory time, relaxation time, minute colume, Penh

Central nervous system:

–          functional observation battery (FOB)

–          Modified Irwin test

–          Motor activity measurement

–          Rotarod

–          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)

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