Stephan Krause, PhD

San Diego


Stephan O. Krause, PhD, is the director of quality at Mpex Pharmaceuticals, Inc.


A Guide for Testing Biopharmaceuticals Part 2: Acceptance criteria and analytical method maintenance

The first part of this article, published in the September 2006 issue, discussed general strategies for validation extensions to other test method components, laboratories and even different test methods.1This second part provides practical tips on how to maintain test method suitability long after the formal completion of analytical method validation (AMV) studies.