Toxicologic Studies for Investigational New Drugs.
Final rept. (Annual) 15 Sep 81-30 Jun 84,
HAZLETON LABS AMERICA INC VIENNA VA
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The general purpose of this program was to provide preclinical animal safety data on candidate antiparasitic test materials. The testing provided acute and subacute toxicity data to meet requirements of the Food and Drug Administration and, specifically, to support data requirements for Investigational New Drug Applications for Phase I and early Phase II clinical studies. Nine drugs WR 6026-2HC1 WR 171,669-HC1 WR 228,258-2HC1 allopurinol riboside WR 231,010 WR 235,591 Formycin B cycloguanil pamoate and WR 180,409 were tested for Walter Reed Army Institute of Research. Each material was evaluated using one or more of the following tests Salmonella typhimuriummammalian microsome plate incorporation assay in vitro chromosomal aberration study in human lymphocytes mouse lymphoma forward toxicity study in mice intramuscular irritation study in rabbits approximate lethal dosemaximum tolerated dose determination study in dogs oral toxicity study in hamsters twenty-eight-day subacute toxicity studies in dogs and rats subchronic studies in rats fertility, teratology, and dogs. Originator supplied keywords include Antiparasitic drugs mutagenicity clastogenicity.