Analytical Methods Validation, Vols. 1-3
This three-volume set from the Institute of Validation Technology offers detailed discussions on achieving compliant analytical methods validation, as well as specific case studies that demonstrate best practices.
More than 15 topics and 200 pages in this PDF-format eProduct include:
• Methods validation & protocol in quality system compliance
• Deriving acceptance criteria for the AMV Protocol
• Case study in reduction of variability in an R&D laboratory
• Use of Monte Carlo simulation to address CMC issues
• Validating immunoassays with fluorescence polarization assay
So long as critical decisions are based on test results, you must strive to ensure accuracy and reproducibility. These compilations show you how!
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