Issue link: https://www.e-digitaleditions.com/i/870536
I Tablets & Capsules September 2017 13 formulation Chris Moreton FinnBrit Consulting While Design of Experiments (DoE) is not mandatory for pre- formulation work, you must always generate good data from scientific studies. Similarly, QbD is not just about what must be done to comply with the regulations. Rather, the focus should be on undertaking risk assessments, making good decisions, and providing justifications based on sound scientific principles. n working with small companies, I've observed that a big concern for them is when to start Quality by Design (QbD). There are many potential options, but QbD only needs to be applied to the final commercial product(s). However, that does not mean that activities undertaken before starting development of the commercial product can be ignored. Since the experience gained using early preclinical and clini- cal formulations will likely be used to support decisions and risk assessments during commercial formulation develop- Using Quality by Design in the formulation of tablets and capsules