An Example of Utilizing Mechanistic and Empirical Modeling in Quality by Design

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 · 211 citations

Pharmacy, Pharmaceutical Analysis, Quality Management +16

PQLI Key Topics - Criticality, Design Space, and Control Strategy

Thomas García, Graham Cook, Roger Nosal · Journal of Pharmaceutical Innovation · 2008 · 94 citations · Full text

Management, Quality Management, Risk Management +14

API Quality by Design Example from the Torcetrapib Manufacturing Process

David J. am Ende, Karen S. Bronk, Jason Mustakis et al. · Journal of Pharmaceutical Innovation · 2007 · 52 citations

Engineering, Manufacturing Engineering, Quality Management +10

Molecular thermodynamics for chemical reaction design

Charles A. Eckert, Cheng-Ting Hsieh, James R. McCabe · AIChE Journal · 1974 · 27 citations

Natural Sciences, Chemical Engineering, Chemistry +16

Development Knowledge Can Increase Manufacturing Capability and Facilitate Quality by Design

Russ Somma · Journal of Pharmaceutical Innovation · 2007 · 24 citations · Full text

Engineering, Design, Manufacturing Engineering +12