So what are the Top Ten List of Analytical Inadequacies in IND and BLA Submissions?
1) Procedural Details
2) System Suitability Tests
3) Representative Instrumental Outputs
4) Types of Validation Characteristics / Test Categorization
5) Linearity in Matrix
6) Verification of “Compendial” Procedures
7) Robustness of Critical Assay Parameters
8) Accuracy Calculations
9) Evaluation of Range
10) Choice of Factors in Intermediate Precision
Why? Download Del Grossso's full presentation here.
This year's perspectives from the FDA come from Lokesh Bhattacharyya, Ph.D., Lab Chief, Laboratory of Analytical Chemistry and Blood Related Products, Division of Biological Standards and Quality Control, CBER, U.S. FDA in the presentation New FDA Draft Guidance on Analytical Procedures and Analytical Method Validation for Drugs and Biologics. For more information on this session, download the agenda. If you'd like to join us November 3-4 in Washington, DC for the Well Characterized Biologicals event, as a reader of this blog when you register to join us and mention code XD14193BLOG, you can save 20% off the standard rate.
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