Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance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.
Articles in this issue
Indirect Photometric Detection in CE Using Buffered Electrolytes — Part I, Principles
Analytical Procedures and Method Validation: Highlights of the FDA's Draft Guidance
Unexpected Peaks
New Directions for Concentration Sensitivity Enhancement in CE and Microchip Technology
Evolution of Capillary Columns for Gas Chromatography
A Protocol for High-Throughput Drug Mixture Quantitation: Fast LC–MS of Flow Injection Analysis–MS
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