Market Overview

Research and Markets: Theory and Practice Pharmaceutical Process Scale-Up


Research and Markets ( has announced the addition of the "Pharmaceutical Process Scale-Up" book to their offering.

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.

Key Topics Covered:

1. Dimensional Analysis and Scale-Up in Theory and Industrial Application

2. Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era

3. Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development

4. Scale-up and Process Validation

5. Parenteral Drug Scale-Up

6. Non-Parenteral Liquids and Semisolids

7. Scale-Up Considerations for Biotechnology-Derived Products

8. Powder Handling

9-1. Batch Size Increase in Dry Blending and Mixing

9-2. Scale Up Of Continuous Blending

10. Scale-Up in the Field of Granulation and Drying

11. Batch Size Increase in Fluid Bed Granulation

12. Roller Compaction Scale-Up

13. Scale-Up of Extrusion and Spheronization

14-1. Scale-Up of Compaction and the Tableting Process

14-2. Dimensional Analysis of the Tableting Process

15. Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations

16. Scale-Up of the Film-Coating

17. Virtual scale-up of manufacturing solid dosage forms

For more information visit

Research and Markets
Laura Wood, Senior Manager.
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Sector: Healthcare and Medical Devices

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