Novel methods for the assessment of safety pharmacology and toxicology parameters in anesthetized and ventilated dogs receiving inhaled drugs.

Affiliation

197 Glasgow Lane, San Carlos, CA 94070, United States. Electronic address: [Email]

Abstract

For nonclinical drug development, it is optimal if safety pharmacology and toxicology studies are performed in a model that reasonably represents the patient the drug is intended to treat. To simulate prolonged inhalation therapy in ventilated patients, GLP inhalation toxicology methods, including safety pharmacology endpoints, in anesthetized, intubated and mechanically ventilated dogs were developed. This model required establishment of a canine intensive care unit (ICU) capable of providing prolonged anesthesia (propofol infusion and morphine titration) and partial parenteral nutrition (dextrose, amino acids and lipids) while safety parameters were monitored.

Keywords

Anesthetized,Blood pressure,Dog,Electrocardiogram,Inhalation,Partial parenteral nutrition,Pulmonary function, clinical pathology, histopathology,Ventilated,