Thought and foresight into method development stages can ensure costly errors and delays are avoided later on. Method development is a critical and continuous process that, if optimized, ensures ...

The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design ...

Recent guidance from regulators emphasizes bioassays and potency assurance strategies, underscoring the robustness of these ...

Analytical methods must be validated to provide reliable data for regulatory submissions. These methods are essential for a number of purposes, including testing for QC release, testing of stability ...