Pharmaceutical Process Scale-Up: Drugs and the Pharmaceutical Sciences
Editat de Michael Levinen Limba Engleză Paperback – 14 oct 2024
- New material on tableting scale-up and compaction.
- Regulatory appendices that cover FDA and EU Guidelines.
- New chapters on risk evaluation and validation as related to scale-up.
- Practical advice on scale-up solutions from world renowned experts in the field.
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Specificații
ISBN-13: 9781032918990
ISBN-10: 1032918993
Pagini: 548
Dimensiuni: 152 x 229 x 33 mm
Greutate: 1.01 kg
Ediția:3
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences
Locul publicării:Boca Raton, United States
ISBN-10: 1032918993
Pagini: 548
Dimensiuni: 152 x 229 x 33 mm
Greutate: 1.01 kg
Ediția:3
Editura: CRC Press
Colecția CRC Press
Seria Drugs and the Pharmaceutical Sciences
Locul publicării:Boca Raton, United States
Public țintă
AcademicCuprins
Dimensional Analysis and Scale-Up in Theory and Industrial Application. Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era. Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development. Scale-up and Process Validation. Parenteral Drug Scale-Up. Non-Parenteral Liquids and Semisolids. Scale-Up Considerations for Biotechnology-Derived Products. Powder Handling. Batch Size Increase in Dry Blending and Mixing . Scale Up Of Continuous Blending. Scale-Up in the Field of Granulation and Drying. Batch Size Increase in Fluid Bed Granulation. Roller Compaction Scale-Up. Scale-Up of Extrusion and Spheronization. Scale-Up of Compaction and the Tableting Process. Dimensional Analysis of the Tableting Process. Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations. Scale-Up of the Film-Coating. Virtual scale-up of manufacturing solid dosage forms. Appendix A: Relevant FDA Guidance for Industry. Appendix B: Relevant EU Directives, Regulations, and Gudelines . Appendix C: Relevant ICH Documents - International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use. Internet link addresses.
Recenzii
Praise for the Previous Edition
"…the text include[s] comprehensive coverage of many of the significant aspects of pharmaceutical scale-up, realistic case studies for nearly each process, and extensive reference lists"
—Pharmaceutical Research
"…the text include[s] comprehensive coverage of many of the significant aspects of pharmaceutical scale-up, realistic case studies for nearly each process, and extensive reference lists"
—Pharmaceutical Research
Descriere
Pharmaceutical Process Scale-Up, Third Edition provides an excellent insight into the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers