GDF 2024 | D2S15 - The Bacterial Endotoxins Specification –Points to Consider
18:02
YouTubeU.S. Food and Drug Administration
GDF 2024 | D2S15 - The Bacterial Endotoxins Specification –Points to Consider
This presentation explained what bacterial endotoxins are and why they pose patient risks in injectable drug products. The session addressed how to control endotoxins in injectable drug products and provided guidance on setting acceptance criteria for release and stability endotoxin specifications. Key considerations for ensuring patient safety ...
184 views4 weeks ago
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