Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance

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LCGC North America

LCGC North America, LCGC North America-01-01-2001, Volume 19, Issue 1

The FDA recently updated its 1987 guidelines for submitting samples and analytical data for method validation — a document that affects all analytical chemists working in the pharmacrutical industry. This article highlights the agency's recommendations of how to report and validate analytical data in all new drug applications.