CLSI EP09-A2 addresses procedures for determining the bias between two clinical methods or devices, and for the design of a method comparison experiment using split patient samples and data analysis.
The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus guidleine for use in satisfying a regulatory requirement.
- Edition:
- Second Edition
- Published:
- 09/20/2002
- ISBN(s):
- 1562384724
- Number of Pages:
- 56
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