Pharmaceutical Process Scale-Up: 3rd Edition (Hardback) book cover

Pharmaceutical Process Scale-Up

3rd Edition

Edited by Michael Levin

CRC Press

530 pages

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Hardback: 9781616310011
pub: 2011-02-02
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Description

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.

Reviews

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

Table of Contents

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

About the Series

Drugs and the Pharmaceutical Sciences

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Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology