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.
Hoyle
P C
PC
Division of Antiviral Drug Products, U.S. Food and Drug Administration, Rockville, Maryland 20875.
Cooper
E C
EC
D000818:Animals; D000998:Antiviral Agents / Q000633:toxicity*; D004353:Drug Evaluation, Preclinical; D006801:Humans; D009626:Terminology as Topic
D000998:Antiviral Agents