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

Stephan Krause, PhD

Articles

QbD for Analytical Methods

The industry needs to open up to validation failures.

Validation Failure is Not an Option. Should it be?

It is essential to understand the critical elements of validation extensions to ensure accurate process or product quality measurements.

Strategies for Validation Extensions

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.

Author | Stephan Krause, PhD