白皮书

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SWOFF The unrecognized yet indispensable sibling of FMO <ul> <li>Find a brief description of FMO controls and their application </li> <li>See how FMO controls can help to avoid false positive classification of events but fail to prevent false negative classification </li> <li>Learn how to use the SWOFF approach to prevent false negative classification of events using existing FMO data sets</li> </ul>
Validation of On-line Total Organic Carbon Analysers for Release Testing Using ICH Q2 This paper discusses how characteristics for consideration during the validation of analytical procedures may be applied to on-line Total Organic Carbon (TOC) analysers to enable them to be used to provide release test data for Water for Injection (WFI) and Purified Water (PW).
AUC Insights - Sample concentration in the Analytical Ultracentrifuge AUC and the relevance of AUC data for the mass of complexes, aggregation content and association constants Sample concentration in the Analytical Ultracentrifuge AUC and the relevance of AUC data for the mass of complexes, aggregation content and association constants
IVD-R Annex I Global Safety and Performances Requirements (GSPR). A New Set of Requirements for Clinical Laboratories Performing Laboratory Developed Tests
Liquid Biopsy Cancer Biomarkers – Current Status, Future Directions We will discuss the current state of liquid biopsy, with a particular focus on cancer genomics. We also discuss some of the keys to success in working with cell-free DNA (cfDNA), and we will finish with future directions of this exciting field.

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