Pharmaceutical Process Scale-Up

Herausgeber: Levin, Michael

• Broschiertes Buch

Produktbeschreibung

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

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Produktdetails

• Drugs and the Pharmaceutical Sciences
• Verlag: Taylor & Francis Ltd
• 3 ed
• Seitenzahl: 548
• Erscheinungstermin: 14. Oktober 2024
• Englisch
• Abmessung: 228mm x 154mm x 33mm
• Gewicht: 776g
• ISBN-13: 9781032918990
• ISBN-10: 1032918993
• Artikelnr.: 71627267

Inhaltsangabe

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.