Keeping pace with the increased influence of PAT in the pharmaceutical industry, this completely updated reference spans the latest research and regulations, technologies, and expert solutions for every significant aspect of pharmaceutical process scale-up-clearly introducing readers to the theoretical concept of dimensional analysis to quantify similar processes on varying scales.
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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. Appendix
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