The safety and quality control of parenteral pharmaceuticals, biologics, and medical devices depend heavily on the Bacterial Endotoxin Test (BET). Historically, Limulus Amebocyte Lysate (LAL), derived ...
Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method
A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to ...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 ...
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 Research ...
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