Quality by Design for Herbal Drugs: a Feedforward Control Strategy and an Approach to Define the Acceptable Ranges of Critical Quality Attributes

Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

Lawrence X. Yu · Pharmaceutical Research · 2008 · 1.1K citations

Industrial Design, Pharmaceutical Supply Chain, Drug Design +11

Quality by design case study: An integrated multivariate approach to drug product and process development

Jun Huang, C.S. Cai, Ramarao Chatlapalli et al. · International Journal of Pharmaceutics · 2009 · 209 citations

Total Quality Management, Industrial Design, Engineering +12

Chemical fingerprint and metabolic fingerprint analysis of Danshen injection by HPLC–UV and HPLC–MS methods

Jinlan Zhang, Ming Cui, Yun He et al. · Journal of Pharmaceutical and Biomedical Analysis · 2004 · 205 citations

Biochemistry, Hplc–ms Methods, Medicine +9

Design space approach in the optimization of the spray-drying process

Pierre Lebrun, Fabrice Krier, Jérôme Mantanus et al. · European Journal of Pharmaceutics and Biopharmaceutics · 2011 · 170 citations

Industrial Design, Design Space Approach, Engineering +7

Quality-by-Design (QbD): An integrated process analytical technology (PAT) approach for a dynamic pharmaceutical co-precipitation process characterization and process design space development☆

Huiquan Wu, Maury White, Mansoor A. Khan · International Journal of Pharmaceutics · 2010 · 108 citations

Process Design, Chemical Engineering, Engineering +8