M. Caphart
Articles
Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance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
January 1st 2001The 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.
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Vol 20 No 12 The Column December 2024 North America PDF
