Method Validation in Pharmaceutical Analysis: A Guide to Best Practice

Authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the analytical quality assurance system.