Historical

M23-A2

Development of In Vitro Susceptibility Testing Criteria and Quality Control Parameters; Approved Guideline-Second Edition

Developed according to this guideline will be used in establishing interpretive and quality control criteria for NCCLS antimicrobial susceptibility testing standards. Human pharmacokinetics, in vitro drug characteristics, distributions of microorganisms, and correlation of test results with outcome statistics are addressed from the perspective of interpretation of test results. In addition, the document Addresses clinical confirmation of interpretive criteria and quality control limits. For clinical confirmation, the "ideal" data set may not be obtained during development of a new drug. Users of this guideline should understand the limitations and work together toward the best educated conclusions. FDA

CONTENT PROVIDER
Clinical And Laboratory Standards Institute [clsi]

Included in Packages
This standard is not included in any packages.
Document History
Revised By:
Amendments & Corrections
We have no amendments or corrections for this standard.