Thomas A. Little, PhD, is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, drlittle@dr-tom.com.

Thomas A. Little, PhD

Articles

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.

Essentials in 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.

Identifying and Controlling CPPs and CMAs

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

Process Characterization Essentials, Model Optimization, and Controlling the Process

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

Author | Thomas A. Little, PhD