Guidelines for nonclinical toxicology studies for chemical warfare agent (CWA) antidotes and pretreatments.
The following is a review of FDA's guidelines for nonclinical toxicology studies as applied to chemical warfare agent (CWA) antidotes and pretreatments. These specific guidelines are of major interest to the U.S. Army Medical Research and Development Command which is a full-scale developer of pharmaceuticals and active in the research and development of antidotes and pretreatments against CWAs. Antidotes and pretreatments against CWAs are unique classes of drugs whose nonclinical requirements are unlike most other pharmaceuticals. However, these guidelines have general applicability to pharmaceutical developers in the private sector and apply to any antidote or pretreatment regardless of the indication.
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Headquarters, U.S. Army Medical Research and Development Command, Ft. Detrick, Maryland 21701.
D000931:Antidotes / Q000633:toxicity*; D002618:Chemical Warfare; D014481:United States; D014486:United States Food and Drug Administration
D000931:Antidotes