Validation of Analytical Methods for Biological Products
4 Guidelines and Guidances FDA Guidance : Analytical Procedures and Methods Validation for Drugs and Biologics – issued July 2015 ICH Q2(R1) Guideline : Validation of Analytical Procedures: Text and Methodology – November 2005 FDA Guidance: Bioanalytical Method Validation USP General Chapter : Validation of Compendial Procedures ... ................
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