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.
Available to download. Prior to purchase please view the download instructions and Terms of Usage.
Format: PDF (1 file 6.11 MB)
Click here to order paper ship version (Item no. 01082).
*To purchase licensing, please contact PDA at [email protected].
Table of Contents:
Click here to download >>> Detailed Table of Contents
- Glossary of Terms
- LER Hold-Time Studies
- Proposed Mechanisms of LER
- Mitigation of LER
- History and Rationale for LER Studies
- Appendix: Case Studies of LER Occurrences
Figures and Tables Index