This four-volume, 265-page set from the Institute of Validation Technology offers detailed discussions on achieving compliant analytical method validation as well as specific case studies that demonstrate best practices. This is a downloadable PDF product — start applying its lessons immediately!
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Validating Immunoassays Using the Fluorescence Polarization Assay for the Diagnosis of Brucellosis David Gall and Klaus NielsenStep-by-Step Analytical Methods Validation and Protocol in the Quality System Compliance Industry Ghulam A. ShabirGood Analytical Method Validation Practice: Setting Up for Compliance and Efficiency: Part I Stephan O. Krause, Ph.D.Good Analytical Method Validation Practice: Deriving Acceptance Criteria for the AMV Protocol: Part II Stephan O. Krause, Ph.D.
Biological Method Validation A Practical Approach Cindy GreenDefining a Master Plan for the Validation of Analytical Methods Paul A. Winslow, Ph.D. and Richard F. Meyer, Ph.D.FDA and Industry Address Analytical Validation Issues for the Pharmaceutical Industry Jerry Lanese, Ph.D.Guidance for Industry Bioanalytical Methods Validation for Human Studies US Food and Drug Adminstration
Method Validation Studies: How GLP Interacts with Guidance Documents Steven S. Kuwahara, Ph.D.Reduction of Analytical Method Variability in an R&D Laboratory: A Case Study Briank K. Nunnally, Andre Johnson, and Raymond KaiseMethod Validation (for Medical Devices) Laure LarkinUse of Monte Carlo Simulation to Address CMC Issues Harry Yang, Ph.D.Validation of Dissolution Methods Gregory P. Martin and Vivian GrayUSP <1010> Analytical Data-Interpretaion and Treatment Appendix E: Compa
Table of ContentsFDA SIgnals a New Approach for Analytical Method Validation by Tim SandleAligning with the New Guidance: FDA Analytical Procedures and Method Validation by Ivan SotoLifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Validation by a USP Validation and Verification Expert Panel