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Respiratory

The ICH S7A Safety Pharmacology (Studies for Human Pharmaceuticals) guidance document states that the effects of the test substance on the respiratory system should be assessed appropriately.  Respiratory rate and other measures of respiratory function (e.g., tidal volume or hemoglobin oxygen saturation) should be evaluated.  Respiratory assessments focus on measures of pulmonary ventilation. Respiratory rate, tidal volume and/or a measure of arterial blood gases as the recommended ventilatory measurement parameters.