1. The application of quality by design to analytical methods;Borman;Pharm. Tech.,2007
2. Implications and opportunities of applying QbD principles to analytical measurements;Schweitzer;Pharm. Tech.,2010
3. Lifecycle management of analytical procedures: method development, procedure performance qualification, and procedure performance verification;Martin;Pharm. Forum,2013
4. Stimuli to the revision process: proposed new USP general chapter: the analytical procedure lifecycle ⟨1220⟩;Martin;Pharm. Forum,2017
5. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (Accessed November 2019) ICH Q8 (R2): Pharmaceutical Development (2009).