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Analytical Method Validation

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  Lane C. SanderChemical Sciences DivisionMaterial Measurement LaboratoryNational Institute of Standards and TechnologyGaithersburg, MD  20899Method validation is a process that is used to demonstrate the suitability of an analytical method for an intended purpose.  Validation procedures have been developed by a variety of industrial committees, regulatory agencies, and standards organizations for purposes of quality control and regulatory compliance.  This presentation is intended to provide an overview of some of the considerations that are commonly included in method validation procedures.  Specific details of method validation are likely to differ for pharmaceutical, clinical, regulatory, or research applications, and the analyst is responsible for insuring that any method validation procedures undertaken fulfill the requirements of the application.

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