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PDA TR 82

M00001887

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

Report / Survey by Parenteral Drug Association, 2019

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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.