Quality By Design Approach To Analytical Method Optimization

Quality by Design (QbD) is well established in the pharmaceutical industry for manufacturing processes, including active pharmaceutical ingredients and drug products. The knowledge obtained during development can establish the design space and determine suitable process controls. The novelty of the multivariate approach over the traditional one-factor-at-a-time (OFAT) type of study is the ability to evaluate both the individual factor effects and the factor-factor interactions that can also be significant.

Download the Case Study