PDA Technical Report No. 82 (TR 82) Low Endotoxin Recovery (single user digital version)

Mar 2019
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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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Table of Contents

Table of Contents:

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  1. Introduction
  2. Glossary of Terms
  3. LER Hold-Time Studies
  4. Proposed Mechanisms of LER
  5. Mitigation of LER
  6. History and Rationale for LER Studies
  7. References
  8. Appendix: Case Studies of LER Occurrences

Figures and Tables Index