General guidelines for clinical bacteriology. Infectious Diseases Society of America and the Food and Drug Administration.

Journal Article

This guideline summarizes recommendations for (1) developing cogent procedures for diagnosis and antimicrobial susceptibility testing; (2) developing quality-control parameters for the microbiological components of clinical trials; (3) continually updating U.S. Food and Drug Administration (FDA) guidelines; (4) reviewing microbiological recommendations from other groups, such as Microbiology Subcommittees of the National Committee for Clinical Laboratory Standards; and (5) improving the microbiological aspects of FDA package inserts for antimicrobial drugs. Sensitive and specific methods for isolation and identification of pathogens are essential to the proper conduct of clinical trials. Susceptibility tests should be performed in an accurate and reproducible fashion. Verification of results in a reference laboratory is encouraged to monitor quality control.

Full Text

Duke Authors

Cited Authors

  • Thrupp, LD; Cleeland, R; Jones, RN; Novick, WJ; Reller, LB; Thornsberry, CL; Washington, JA

Published Date

  • November 1992

Published In

Volume / Issue

  • 15 Suppl 1 /

Start / End Page

  • S339 - S346

PubMed ID

  • 1477249

International Standard Serial Number (ISSN)

  • 1058-4838

Language

  • eng

Conference Location

  • United States