Pharmaceutical Process Scale-Up

Michael Levin

$96.99

Paperback

Not in-store but you can order this
How long will it take?

Availability Information

We source books from suppliers in Australia and overseas. For books we don't currently have in stock, the time it takes to get them from our suppliers can vary widely - from a few days to a few months - so we check each book with each supplier to determine the expected time it will take to be supplied to us.

We then advise you accordingly. If the time taken to get any book is too long for you, you can let us know and we will cancel or adjust your order, and refund as required.

To find out the anticipated arrival time for specific items prior to ordering, please contact us by phone or email:

Phone +61 2 9264 3111, or 1800 4 BOOKS (1800 4 26657) if outside Sydney:
option 1 Abbey's Bookshop (Crime, History, Science, Kids & more) • info@abbeys.com.au
option 2 Language Book Centre (ESL & Foreign Languages) • language@abbeys.com.au
option 3 Galaxy Bookshop (Sci-fi, Fantasy, Romance, Graphic Novels) • sf@galaxybooks.com.au

QTY:

English

CRC Press
14 October 2024

Manufacturing industries; Engineering: general; Pharmaceutical technology

Series: Drugs and the Pharmaceutical Sciences

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.

Edited by: Michael Levin
Imprint: CRC Press
Country of Publication: United Kingdom
Edition: 3rd edition
Dimensions: Height: 229mm, Width: 152mm,
Weight: 1.010kg
ISBN: 9781032918990
ISBN 10: 1032918993
Series: Drugs and the Pharmaceutical Sciences
Pages: 548
Publication Date: 14 October 2024
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

Dimensional Analysis and Scale-Up in Theory and Industrial Application. Engineering Approaches for Pharmaceutical Process Scale-up, Validation, Optimization, and Control in the PAT Era. Understanding Scale Up and Quality Risks on the interface between Primary and Secondary Development. Scale-up and Process Validation. Parenteral Drug Scale-Up. Non-Parenteral Liquids and Semisolids. Scale-Up Considerations for Biotechnology-Derived Products. Powder Handling. Batch Size Increase in Dry Blending and Mixing . Scale Up Of Continuous Blending. Scale-Up in the Field of Granulation and Drying. Batch Size Increase in Fluid Bed Granulation. Roller Compaction Scale-Up. Scale-Up of Extrusion and Spheronization. Scale-Up of Compaction and the Tableting Process. Dimensional Analysis of the Tableting Process. Practical Considerations in the Scale-Up of Powder-Filled Hard Shell Capsule Formulations. Scale-Up of the Film-Coating. Virtual scale-up of manufacturing solid dosage forms. 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.

Reviews for Pharmaceutical Process Scale-Up

"Praise for the Previous Edition ""…the text include[s] comprehensive coverage of many of the significant aspects of pharmaceutical scale-up, realistic case studies for nearly each process, and extensive reference lists"" —Pharmaceutical Research"