Metropolitan Computing Corporation, East Hanover, NJ. Provides insight into the practical aspects of process scale-up and interesting reading for those involved in technology transfer and product globalization.
This reference spans the latest research, regulations, technologies, and solutions for pharmaceutical process scale-up, and introduces the theoretical concept of dimensional analysis to quantify similar processes on varying scales.
An ideal text all those involved in pharmaceutical batch enlargement, this text includes:
- trade secrets and recommendations from professionals in the field
- revised chapters on scale-up theory and scale-up of parenteral drugs, liquids, and semi-solids; biotechnology products; blending/mixing; granulation and drying; tableting; and FDA perspectives
- new sections on roller compaction, extrusion and spheronizing, encapsulation, and PAT aspects of scale-up engineering
- scale-up/post-approval changes and references relating to FDA regulations
- transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale
- new directions in industry and SUPAC and PAT guidelines
- Taken from Informa Healthcare.
Price: £ 115.00
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