Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance

E. Leutzinger;R. Frankewich;P. Faustino;R. Rajagopalan;Y. Chiu;L. Ng;R. Brown;J. Gibbs;E. Sheinin;G. Lunn;M. Caphart;

Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance

Published on: 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.