- 1. Dimensional Analysis and Scale-Up in Theory and Industrial Application - Marko Zlokarnik (Graz, Austria)
- 2. Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era - Fernando Muzzio (Rutgers University)
- 3. Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development - Frans L. Muller, Kathryn A. Gray and Graham E. Robinson (AstraZeneca)
- 4. Scale-up and Process Validation - Steven Ostrove (Ostrove Associates)
- 5. Parenteral Drug Scale-Up - Igor Gorsky (Shire)
- 6. Non-Parenteral Liquids and Semisolids - Lawrence H. Block (Duquesne University)
- 7. Scale-Up Considerations for Biotechnology-Derived Products - Marco A. Cacciuttolo, John Chon, Greg Zarbis-Papastoitsis (Percivia)
- 8. Powder Handling - James K. Prescott (Jenike & Johanson)
- 9-1. Batch Size Increase in Dry Blending and Mixing - Albert W. Alexander and Fernando J. Muzzio (Rutgers University)
- 9-2. Scale Up Of Continuous Blending - Aditya U. Vanarase, Yijie Gao, Atul Dubey, Marianthi G. Ierapetritou, and Fernando J. Muzzio (Rutgers University)
- 10. Scale-Up in the Field of Granulation and Drying - Hans Leuenberger (Ifiip GmbH) and Gabriele Betz (University of Basel)
- 11. Batch Size Increase in Fluid Bed Granulation - Dilip M. Parikh (DPharma Group
- 12. Roller Compaction Scale-Up - Ronald Miller (Miller Pharmaceutical Technology Consulting)
- 13. Scale-Up of Extrusion and Spheronization - Raman Iyer, Harpreet K. Sandhu and Navnit Shah (Hoffman-LaRoche
- 14-1. Scale-Up of Compaction and the Tableting Process - Matthew P. Mullarney and Jeffrey Moriarty (Pfizer)
- 14-2. Dimensional Analysis of the Tableting Process - Michael Levin (Milev Pharmaceutical Technology Consulting) and Marko Zlokarnik (Graz, Austria)
- 15. Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations - Larry Augsburger (University of Maryland)
- 16. Scale-Up of the Film-Coating - Stuart Porter (International Specialty Products)
- 17. Virtual scale-up of manufacturing solid dosage forms - Hans Leuenberger (Ifiip GmbH), Michael N. Leuenberger (2AMIFICAS, Inc.) and Maxim Puchkov (CINCAP GmbH)
Appendix A: Relevant FDA Guidance for Industry – Internet link addresses
Appendix B: Relevant EU Directives, Regulations, and Gudelines – Internet link addresses
Appendix C: Relevant ICH Documents - International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use – Internet link addresses
Index
Michael Levin has over 25 years of experience in the field of pharmaceutical scale-up, instrumentation and process optimization. He currently runs his own company Milev Pharmaceutical Technology Consulting. A former teacher of courses on wet granulation and tableting. Mike has a PhD. in BioMathematics (1980) from the University of Washington in Seattle and completed his Post Doctorate at the University of Houston, Department of Mechanical Engineering.

