PDA Technical Report No. 82 (TR 82) Low Endotoxin Recovery (single user digital version)
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This Technical Report 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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Format: PDF (1 file 6.11 MB)
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Table of Contents
Table of Contents:
Click here to download >>> Detailed Table of Contents- Introduction
- Glossary of Terms
- LER Hold-Time Studies
- Proposed Mechanisms of LER
- Mitigation of LER
- History and Rationale for LER Studies
- References
- Appendix: Case Studies of LER Occurrences
Figures and Tables Index