The ability to define a scientifically justified and statistically sound sampling procedure is a fundamental skill in modern systematic drug development.
Design space generation is encouraged in new product development.
Characterization of stability performance provides a clear, statistically defendable method for determining accelerated stability.
Design of experiment is a powerful development tool for method characterization and method validation.
Knowledge of product or process acceptance criterion is crucial in design space.
The author discusses the need for stability analysis.
Quality risk management is an essential element of every aspect of drug development and manufacturing throughout the product lifecycle.
A 10-step systematic approach to analytical method development and validation can improve the quality of drug development.
Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs.