Pharmaceutical Process Scale-Up (Hardcover, 3)

Dimensional Analysis and Scale-Up in Theory and Industrial Application
Marko Zlokarnik
Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era
Fernando Muzzio
Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development
Frans L. Muller, Kathryn A. Gray, and Graham E. Robinson
Scale-up and Process Validation
Steven Ostrove
Parenteral Drug Scale-Up
Igor Gorsky
Non-Parenteral Liquids and Semisolids
Lawrence H. Block
Scale-Up Considerations for Biotechnology-Derived Products
Marco A. Cacciuttolo, John Chon, and Greg Zarbis-Papastoitsis
Powder Handling
James K. Prescott
Batch Size Increase in Dry Blending and Mixing
Albert W. Alexander and Fernando J. Muzzio
Scale Up Of Continuous Blending
Aditya U. Vanarase, Yijie Gao, Atul Dubey, Marianthi G. Ierapetritou, and Fernando J. Muzzio
Scale-Up in the Field of Granulation and Drying
Hans Leuenberger and Gabriele Betz
Batch Size Increase in Fluid Bed Granulation
Dilip M. Parikh
Roller Compaction Scale-Up
Ronald Miller
Scale-Up of Extrusion and Spheronization
Raman Iyer, Harpreet K. Sandhu and Navnit Shah
Scale-Up of Compaction and the Tableting Process
Matthew P. Mullarney and Jeffrey Moriarty
Dimensional Analysis of the Tableting Process
Michael Levin and Marko Zlokarnik
Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations
Larry Augsburger
Scale-Up of the Film-Coating
Stuart Porter
Virtual scale-up of manufacturing solid dosage forms
Hans Leuenberger, Michael N. Leuenberger, and Maxim Puchkov

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
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