Regulatory Review of Method Validation Protocols

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LCGC North America, June 2000, Volume 18, Issue 06
Pages: 620–625

This month's "Validation Viewpoint" column examines the reasons behind problems with new drug applications submitted to the U.S. Food and Drug Administration (FDA). Ira Krull and Michael Swartz look at specific problems within analytical methods that raise red flags at the FDA.