PDA TR 82

Technical Report No. 82 (TR 82) Low Endotoxin Recovery

Parenteral Drug Association , 2019

Publisher: PDA

File Format: PDF

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PDA TR 82 aims to describe the underlying mechanisms and contributing factors of LER, summarize the potential clinical impact of the LER phenomenon, present guidelines for developing LER hold-time study design, and provide strategies for the mitigation of LER.

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