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Pharmaceutical Book from C.H.I.P.S.

Pharmaceutical Process Scale-Up
Second Edition
edited by Michael Levin

Pharmaceutical Process Scale-Up spans the latest research and regulations, technologies, and expert solutions for every significant aspect of pharmaceutical process scale-up.

Features:

  • Contains practical trade secrets and hands-on recommendations from seasoned professionals in the field
  • Provides completely revised chapters on scale-up theory and the scale-up of parenteral drugs, liquids, and semi-solids; biotechnology products; blending and mixing; granulation and drying; tableting; and FDA perspectives
  • Contains entirely new sections on roller compaction, extrusion and spheronizing, encapsulation, and PAT aspects of scale-up engineering
  • Addresses the regulatory aspects of scale-up and post-approval changes and lists all references relating to FDA regulations
  • Concentrates on the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale
  • Focuses on new directions in industry-showcasing the increasing emphasis on SUPAC and PAT guidelines

Contents

  • 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
  • Parenteral Drug Scale-Up
  • Non-Parenteral Liquids and Semi-Solids
  • Scale-Up Considerations for Biotechnology Derived Products
  • Batch Size Increase in Dry Blending and Mixing
  • Batch Size Increase and: Powder Handling
  • Scale-Up in the Field of Granulation and Drying
  • Scale-Up of Roller Compaction Process
  • Batch Size Increase in Fluid Bed Granulation
  • Scale-Up of Extrusion and Spheronizing
  • Scale-Up of Compaction and Tableting Process
  • Practical Considerations in the Scale Up of Powder-Filled Hard Shell Capsule Formulations
  • Scale-Up of the Film-Coating Process
  • Innovation and Continuous Improvement in Pharmaceutical Manufacturing

Index

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Pharmaceutical Process Scale-Up
Second Edition
edited by Michael Levin

2005 576 pages $228.95 + shipping
Texas residents please add 6.75 % sales tax

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