Nonclinical toxicity studies of antiviral drugs indicated for the treatment of non-life-threatening diseases: evaluation of drug toxicity prior to phase 1 clinical studies.
The types of nonclinical toxicity studies conducted during the preclinical research and development of antiviral drugs intended for the treatment of non-life-threatening diseases in humans are reviewed. This guidance also applies to other classes of drugs under development for non-life-threatening diseases that fall under the regulatory responsibility of the Food and Drug Administration's Division of Antiviral Drug Products, including systemic antifungals, antimycobacterials, and immunomodulators.
Division of Antiviral Drug Products, U.S. Food and Drug Administration, Rockville, Maryland 20875.
P C
PC
Hoyle
E C
EC
Cooper
D000818:Animals; D000998:Antiviral Agents / Q000633:toxicity*; D004353:Drug Evaluation, Preclinical; D006801:Humans; D009626:Terminology as Topic
D000998:Antiviral Agents