Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance

Article

LCGC North America

LCGC North AmericaLCGC 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.

Related Videos
Toby Astill | Image Credit: © Thermo Fisher Scientific
Robert Kennedy