Comprehensive non-clinical respiratory evaluation of promising new drugs.
The need to evaluate the potential for new drugs to produce adverse effects on respiratory function in non-clinical safety assessment is based on the known effects of drugs from a variety of pharmacological/therapeutic classes on the respiratory system, the life-threatening consequences of respiratory dysfunction, and compliance with world-wide regulatory safety guidelines. The objective of this article is to provide a brief overview of the functional disorders of the respiratory system and to present the strategy and techniques considered to be most appropriate for detecting and characterizing drug-induced respiratory disorders in non-clinical safety studies.
Murphy
Dennis J
DJ
Department of Safety Pharmacology, GlaxoSmithKline Pharmaceuticals, 709 Swedeland Road, King of Prussia, PA 19406, USA. dennis.j.murphy@GSK.com
D000818:Animals; D004353:Drug Evaluation, Preclinical; D006801:Humans; D010991:Plethysmography; D012119:Respiration / Q000187:drug effects*; D012129:Respiratory Function Tests