Articles by Alex D. Kanarek, PhD - BioPharm International

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Articles by Alex D. Kanarek, PhD

Alex D. Kanarek, PhD


Method Validation Guidelines
September 15, 2005

"The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose" (International Conference on Harmonisation Guideline Q2A).1 "Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use" (US Food and Drug Administration Draft Guidance for Industry, 2000 ).2

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