Toxicologic Studies for Investigational New Drugs.

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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.

Author(s):
Reno, Frederick E. ; Cox, Raymond H. ; Trutter, Janet A. ; Voelker, Richard W.
Author Organization(s):
HAZLETON LABS AMERICA INC VIENNA VA
Descriptive Note:
Annual rept. 1 May 82-31 May 83,
Pagination:
0017

Security Markings

DOCUMENT & CONTEXTUAL SUMMARY

Distribution:
Approved For Public Release
Distribution Statement:
Approved For Public Release; Distribution Unlimited.

RECORD

Collection: TR
Identifying Numbers
Contract/Grant Number(s):
DAMD17-81-C-1138
Task Number(s):
AF
Project Number(s):
3M162770A871
 Subject Terms
Communities of Interest:
No COI(s) Identified
Descriptor(s):
*TOXICITY, *ANTIPARASITIC DRUGS, SUBCUTANEOUS TISSUE, MICE, DRUGS, FOOD, REQUIREMENTS, TOXICOLOGY, CLINICAL MEDICINE, SAFETY, REVERSIBLE, RATS, FERTILITY, REPRODUCTION(PHYSIOLOGY)
Field(s)/Group(s):
Toxicology, Pharmacology
Keyword(s):
WR 228, 258 HCL antiparastic drugs, WR 141, 669 HCL antiparasitic drugs, Teratology, PE62770A, AS871, WU097
Report Date:
1983 Jun 01