chapter  1
46 Pages

Designing Experiments for Validation of Quantitative Methods

ByT. Lynn Eudey

Quantitative methods are assays that result in meaningful numeric measurements for a characteristic of a product. Quantitative methods are used in assessing whether final product meets specifications. They are also used to measure product quality (or quantity) in various stages of manufacturing and the results are often used in quality control charts. Validation is an objective process used to determine whether a quantitative method is performing as expected and is appropriate for its intended use. This chapter provides the motivation behind validation, some terms and definitions used in validation, a consolidated statistically sound approach to validation, along with appropriate statistical analysis, and reporting of validation results. A hypothetical but realistic example is presented and is used to illustrate the validation process.