Pharmaceutical Process Scale-Up

Abstract

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 Internet link addresses