Quality by Design for Analytical Methods In Early Development

In Phase 1 and 2 a high attrition rate and continuously changing targets can make spending resources of QbD activities seem very unattractive.  However, applying many of the QbD principles early in the lifecycle can payoff with decreased method development time, fewer changes required due to poor method performance and a better understanding of method capability and risks.  Column screening systems and modeling tools are often used in early development to identify and optimize separation conditions.  Other tools such as risk assessments and method performance monitoring are less commonly used.  Examples of early analytical development QbD approaches will be presented.