Thomas A. Little

Correct organization and appropriate methods for demonstrating biosimilar comparability are important for supporting regulatory filings.

Developing analytical methods and bioassays is necessary from early on in the drug development life cycle.

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.

Knowing how method performance impacts out-of-specification rates may improve quality risk management and product knowledge.

Specification limits should be set early in drug development and refined in later phases as data becomes available.

The author describes common components of a relative potency bioassay and provides a framework for assay development, calculation, and control.

This article defines the concept, justification, and method of removal of out-of-trend points in stability modelling and shelf-life prediction.