Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment

Article ID	Journal	Published Year	Pages	File Type
8520769	International Journal of Pharmaceutics	2017	30 Pages	PDF

Keywords

NOR EMA CQA CMA GMP API NIR PLS DOE CPP LVM ANN FMEA OOS ISPE MSPC Dem OOT PCA European Medicines agency Principal component analysis Good Manufacturing Practice Par Process analytical technology Failure mode and effects analysis CFD Computational fluid dynamics Finite element method Discrete element method artificial neural networks Design of experiments Latent variable modeling ICH Active Pharmaceutical Ingredient In vitro-in vivo correlation IVIVC Critical quality attribute pat critical process parameter FEM Multivariate statistical process control International Conference on Harmonization

Related Topics

Health Sciences Pharmacology, Toxicology and Pharmaceutical Science Pharmaceutical Science

Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment

Authors

Jelena Djuris, Zorica Djuric,