Accession Number : ADB108614

Title :   Toxicologic Studies for Investigational New Drugs.

Descriptive Note : Annual rept. 1 May 82-31 May 83,

Corporate Author : HAZLETON LABS AMERICA INC VIENNA VA

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

Report Date : JUN 1983

Pagination or Media Count : 17

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.

Descriptors :   *TOXICITY, *ANTIPARASITIC DRUGS, SUBCUTANEOUS TISSUE, MICE, DRUGS, FOOD, REQUIREMENTS, TOXICOLOGY, CLINICAL MEDICINE, SAFETY, REVERSIBLE, RATS, FERTILITY, REPRODUCTION(PHYSIOLOGY).

Subject Categories : Toxicology
      Pharmacology

Distribution Statement : APPROVED FOR PUBLIC RELEASE