Predictive Modeling of Pharmaceutical Unit Operations
Editat de Preetanshu Pandey, Rahul Bharadwajen Limba Engleză Hardback – 5 oct 2016
by Design (QbD) principles during manufacturing, reliable modeling techniques can help to alleviate the costs associated with such efforts, and be used to create in silico formulation and process design space. This book is geared toward detailing modeling techniques that are utilized for the various unit operations during drug product manufacturing. By way of examples that include case studies, various modeling principles are explained for the nonexpert end users. A discussion on the role of modeling in quality risk management for manufacturing and application of modeling for continuous manufacturing and biologics is also included.
- Explains the commonly used modeling and simulation tools
- Details the modeling of various unit operations commonly utilized in solid dosage drug product manufacturing
- Practical examples of the application of modeling tools through case studies
- Discussion of modeling techniques used for a risk-based approach to regulatory filings
- Explores the usage of modeling in upcoming areas such as continuous manufacturing and biologics manufacturingBullet points
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Specificații
ISBN-13: 9780081001547
ISBN-10: 0081001541
Pagini: 464
Dimensiuni: 152 x 229 x 23 mm
Greutate: 0.86 kg
Editura: ELSEVIER SCIENCE
ISBN-10: 0081001541
Pagini: 464
Dimensiuni: 152 x 229 x 23 mm
Greutate: 0.86 kg
Editura: ELSEVIER SCIENCE
Cuprins
1. Modeling of drug product manufacturing processes in the pharmaceutical industry
2. Quality risk management for pharmaceutical manufacturing: The role of process modeling and simulations
3. Powder flow and blending
4. Dry granulation process modeling
5. Mechanistic modeling of high-shear and twin screw mixer granulation processes
6. Fluid bed granulation and drying
7. Modeling of milling processes via DEM, PBM, and microhydrodynamics
8. Modeling of powder compaction with the drucker–prager cap model
9. Modeling approaches to multilayer tableting
10. Computational modeling of pharmaceutical die filling processes
11. Modeling tablet film-coating processes
12. Modeling in pharmaceutical packaging
13. Continuous secondary process selection and the modeling of batch and continuous wet granulation
14. Process modeling in the biopharmaceutical industry
2. Quality risk management for pharmaceutical manufacturing: The role of process modeling and simulations
3. Powder flow and blending
4. Dry granulation process modeling
5. Mechanistic modeling of high-shear and twin screw mixer granulation processes
6. Fluid bed granulation and drying
7. Modeling of milling processes via DEM, PBM, and microhydrodynamics
8. Modeling of powder compaction with the drucker–prager cap model
9. Modeling approaches to multilayer tableting
10. Computational modeling of pharmaceutical die filling processes
11. Modeling tablet film-coating processes
12. Modeling in pharmaceutical packaging
13. Continuous secondary process selection and the modeling of batch and continuous wet granulation
14. Process modeling in the biopharmaceutical industry