Levin Pharmaceutical Process Scale-Up

3. New Auflage 2011
ISBN: 978-1-61631-001-1
Verlag: Taylor & Francis Inc

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Beschreibung

The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes:

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.
Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to 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. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

Autoren

Herausgeber

Levin, Michael

Inhaltsverzeichnis

Dimensional Analysis and Scale-Up in Theory and Industrial ApplicationMarko ZlokarnikEngineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT EraFernando MuzzioUnderstanding Scale Up and Quality Risks on the interface between Primary and Secondary DevelopmentFrans L. Muller, Kathryn A. Gray, and Graham E. RobinsonScale-up and Process ValidationSteven Ostrove Parenteral Drug Scale-UpIgor GorskyNon-Parenteral Liquids and SemisolidsLawrence H. BlockScale-Up Considerations for Biotechnology-Derived ProductsMarco A. Cacciuttolo, John Chon, and Greg Zarbis-PapastoitsisPowder HandlingJames K. PrescottBatch Size Increase in Dry Blending and Mixing Albert W. Alexander and Fernando J. MuzzioScale Up Of Continuous Blending Aditya U. Vanarase, Yijie Gao, Atul Dubey, Marianthi G. Ierapetritou, and Fernando J. MuzzioScale-Up in the Field of Granulation and DryingHans Leuenberger and Gabriele Betz Batch Size Increase in Fluid Bed GranulationDilip M. Parikh Roller Compaction Scale-UpRonald MillerScale-Up of Extrusion and SpheronizationRaman Iyer, Harpreet K. Sandhu and Navnit Shah Scale-Up of Compaction and the Tableting ProcessMatthew P. Mullarney and Jeffrey MoriartyDimensional Analysis of the Tableting ProcessMichael Levin and Marko Zlokarnik Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule FormulationsLarry AugsburgerScale-Up of the Film-CoatingStuart Porter Virtual scale-up of manufacturing solid dosage formsHans Leuenberger, Michael N. Leuenberger, and Maxim PuchkovAppendix 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 UseInternet link addresses

Zielgruppe

Pharmacists, pharmacologists, chemical and process engineers, pharmaceutical scientists and manufacturers, bioprocess technologists, plant and operating personnel, and upper-level undergraduate and graduate students in these disciplines.

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