Toxicity is one of the leading causes for candidate rejection during drug development. As a result, many scientists recognize the importance of including exploratory toxicology studies during the preclinical drug discovery phase, to minimize the risk of failure at the clinical level due to toxicological liabilities. When looking specifically at the field of respiratory drug discovery and development, these exploratory toxicology studies must provide physiologically-relevant, reproducible and translational data.
During exploratory toxicology studies, the safety of a potential respiratory drug candidate can be evaluated by studying its impact on lung function. In-depth measurements using the flexiVent are acquired in a controlled experimental environment which provides highly reproducible, detailed outcomes that can prevent drug candidates with a safety risk from entering clinical development and also assist in understanding the toxicological properties of the drug candidate early on in the process to avoid costly late-stage failures.
Performing toxicology studies in relevant, practical animal models is key for translating the outcomes from the preclinical environment into understanding its toxicity risk in clinical trials. The inExpose is a compact and customizable inhalation exposure system, which provides a reproducible way of exposing animals to a drug candidate, creating relevant and reproductible animal models. The system offers sophisticated computer control for automated, precise, and repeatable aerosolised drug delivery using aerosol generation devices. Another highlight of the inExpose is that it offers small internal volumes which prevents unintended dilution of the drug candidate and removes the need for large quantities, further reducing costs.
Non-invasive plethysmography techniques such as whole body plethysmography (WBP), double chamber plethysmography (DCP), or head-out plethysmography (HOP) can be used in exploratory toxicology studies to asses the toxicity risk of a candidate drug in conscious animals. This technique provides essential physiological information related to changes in respiratory function measurements such as tidal volume (Vt), respiratory rate (RR) and minute ventilation (MV).
Airway obstruction is one of the leading respiratory difficulties encountered during clinical trials of a drug candidate and although these techniques provide the advantage of assessment of respiratory function measurements, independent of anaesthetic side effects, the drawback is that these techniques do not provide information related to lung mechanics such as airway resistance.
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