Accession Number : ADB068920

Title :   Toxicologic Studies for Investigational New Drugs.

Descriptive Note : Annual rept. Sep 81-Apr 82,

Corporate Author : HAZLETON LABS AMERICA INC VIENNA VA

Personal Author(s) : Reno, Frederick E. ; Trutter, Janet A. ; Voelker, Richard W.

Report Date : MAY 1982

Pagination or Media Count : 13

Abstract : This annual report presents the results of three toxicological studies on an investigational new drug completed from 15 September 1981 through 30 April 1982 and perfromed under contract to the U.S. Army Medical Research and Development Command under the term from 15 September 1981 through 31 July 1982. 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. One drug (WR 6026-2HCl) has been tested for Walter Reed Army Institute of Research. An approximate lethal dose/maximum tolerated dose determination study in dogs and twenty-eight-day subacute studies in dogs and rats were performed from 8 October 1981 through 25 November 1981. Interim reports giving findings were issued on 3 March 1982 and 26 March 1982.

Descriptors :   *TOXICITY, *DRUGS, *ANTIPARASITIC DRUGS, TEST METHODS, REQUIREMENTS, STANDARDS, TOLERANCES(PHYSIOLOGY), LETHAL DOSAGE, LABORATORY ANIMALS, SAFETY, DOGS, RATS.

Subject Categories : Toxicology
      Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE