Umetrics Suite Blog

Creating a design of experiments study to predict formula robustness

November 9, 2017

Using a Quality by Design (QbD) approach for DOE supports ICH Q8 compliance

In pharmaceutical development, manufacturers must be able to demonstrate product robustness and deliver the intended quality of the product within allowable ranges for the claimed shelf-life period. Both international and country specific regulatory agencies, such as the FDA, pay close attention to these claims.

Read More