抄録
A critical but challenging aspect of inhalation cardiorespiratory safety pharmacology studies is the collection of high quality cardiovascular and respiratory data immediately prior to, during and immediately after dose in order to recognize any acute effects of the inhaled test article. This poster describes methods for achieving a successful outcome in studies, including factors that must be considered in the design and execution. Effects of proper habituation to equipment and carefully scheduled study activities were assessed based on the overall character of cardiorespiratory response from 3 different studies. Prior to data collection, all animals were surgically implanted with telemetry transmitters and habituated to the exposure/data collection system. Telemetry data were collected continuously for 2 hours while animals were in their home cage, after transfer to the exposure suite for 0.5 hours prior to air or vehicle exposure, during the 1 hour exposure, 0.5 hour after exposure and for 24 hours post dose. Each study used a different vehicle and an air (sham) control was administered for assessment of the vehicle effect. Administration of the vehicle produced no effects on blood pressure, heart rate, body temperature, respiratory rate, tidal and minute volume, when compared to the air control in all 3 studies. These data confirm we have developed a reliable method of collecting cardiorespiratory parameters in inhalation safety studies.
