title: General method validation guidelines for pharmaceutical samples.
abstract: Method validation guidelines, which provide an organizational structure for the design and evaluation of a validation procedure, are presented for a wide range of pharmaceutical applications. The validation guidelines are based on the analyte concentration/sample matrix combination to which the method will be applied. These guidelines include the selection of appropriate validation parameters, design considerations for evaluation, and a discussion of acceptance guidelines for the determination of acceptable method performance. A set of tables is included which illustrates the selection and testing procedure and tailors the entire validation process to the specific characteristics of the determination to be made.
mesh_terms: D002626:Chemistry, Pharmaceutical; D004355:Drug Stability; D004364:Pharmaceutical Preparations / Q000032:analysis*; D012015:Reference Standards
chemical_list: D004364:Pharmaceutical Preparations