Toxicologic Studies for Investigational New Drugs.

Abstract

This annual report presents the results of six toxicological studies on two investigational new drugs completed from 1 May 1982 through 31 May 1983. The general purpose of this program is to provide preclinical animal safety data on candidate antiparasitic test materials. The testing program provides 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. Two drugs (WR 141,669.HC1 and WR 228,258.2HC1) have been tested for Walter Reed Army Institute of Research. WR 171,669.HC1 was evaluated using the following tests: acute subcutaneous toxicity study in mice and toxicity reversal study in rats.

Document Details

Document Type
Technical Report
Publication Date
Jun 01, 1983
Accession Number
ADB108614

Entities

People

  • Frederick E. Reno
  • Janet A. Trutter
  • Raymond H. Cox
  • Richard W. Voelker

Tags

DTIC Thesaurus Topics

  • Toxicity

Readers

  • Clinical Trial Research.
  • Parasitology and Pharmacology of Malaria.
  • Toxicology/Environmental Toxicology