PMF Newsletter February 2013

In this issue, Dr. Michael Miller discusses the current state of Rapid Microbiological Methods (RMMs). His discussion includes Quality, regulatory and validation considerations.

Dr. Tim Sandle presents an article addressing the variability of the Limulus amebocyte lysate (LAL) assay. This compendial test for bacterial endotoxin has several aspects of inherent variability. Dr. Sandle discusses each area, and provides recommendations for statistical analyses.

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