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Chromatographic Method Validation: A Review of Current Practices and Procedures. II. Guidelines for Primary Validation Parameters.

1996; Taylor & Francis; Volume: 19; Issue: 5 Linguagem: Inglês

10.1080/10826079608005534

1520-572X

Dennis Jenke,

Pesticide Residue Analysis and Safety

Abstract Validation of analytical methodologies is an important aspect of their development/utilization and is widely required in support of product registration applications. In this manuscript, definitions, procedures and acceptance criteria which appear in the pharmaceutical literature are summarized for the more commonly encountered validation parameters. Parameters examined include accuracy, precision, specificity, linearity and sensitivity limits.