Product-specific methods emphasize analytical procedure selection, system suitability tests, and assay performance criteria to improve consistency across biologic and biosimilar quality attribute ...
USP is developing digital reference standards to integrate into modern digital environments, enhancing regulatory confidence and quality consistency. Compendial pathways are being established to ...
DUBLIN--(BUSINESS WIRE)--The "Validation, Verification and Transfer of Analytical Methods (Understanding and implementing guidelines from FDA/EMA, USP and ICH)" conference has been added to ...
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