Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance

January 1, 2001
E. Leutzinger

,
R. Frankewich

,
P. Faustino

,
R. Rajagopalan

,
Y. Chiu

,
L. Ng

,
R. Brown

,
J. Gibbs

,
E. Sheinin

,
G. Lunn

,
M. Caphart

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.