Respiratory Toxicity Reasons for Adequate Translation from Animal to Human

2 Respiratory Toxicity Reasons for Adequate Translation from Animal to Human 

Prior to administration of an NCE in humans, the compound s effect on respiratory function is evaluated in a non-clinical setting (typically in a rodent) as per ICH S7A. Simple visual inspection is not considered adequate, so quantitative measurements (tidal volume and minute volume) in addition to respiratory rate are recorded. While quantitative assessment is typically conducted with singledose administration, microscopic evaluation of the lung, trachea, and nasal passages are conducted as part of the repeat-dose administration toxicology studies. 

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