Thomas A. Little, PhD

Developing an effective bioassay is crucial for determining the potency of a drug substance or finished drug product. This article gives an overview of how to avoid most problems associated with correct bioassay development.

Statistical methods to identify critical process parameters and critical material attributes-and approaches to control them-are needed to protect drug product and drug substances.

This article examines how process characterization is crucial to process understanding and then applying that understanding to controlling a process.

Process characterization and model building are essential skills and are required for modern drug development.