Drug Assessment Plan for the Evaluation of Antivesicant Pretreatment andTreatment Compounds

摘要

The Antivesicant PIT Plan is designed to rapidly identify compounds which, whengiven orally or parenterally before or shortly after vesicant exposure, will be effective in the prevention or reduction of vesicant-induced cutaneous injury. Antivesicant compounds. are being considered for both pretreatment and treatment modalities. Pretreatment refers to the administration of compound before exposure to vesicants, whereas treatment refers to the administration of compound after exposure but before the onset of incapacitating signs. In both Cases, the aim is to prevent or reduce the lesions associated with vesicating agents. This plan is not designed to identify compounds which, when given after the development of lesions, will speed healing of those lesions. Ideally, both pretreatments and treatments should be void of undesirable side effects since administration of the drugs would occur before the onset of incapacitating lesions.