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Freeze Drying: Scale-Up Considerations
- Introduction
- Development of a Freeze-Drying Cycle
- Transfer Technology and Scale-Up of a Freeze-Drying Cycle
- Freezing Phase
- Primary Drying Phase
- Sources of Variability and Qualification of the Equipment
- Scale-Up Via Robust Recipe
- Scale-Up Via Mathematical Modeling
- Scale-Up Via Process Control
- Secondary Drying Phase
- Conclusions
- Articles of Further Interest
- References
Abstract
The pathway that brings a new drug to the market is the result of a series of controlled trials, which aim to test its safety and efficacy. After a preclinical phase, wherein the tests are carried out in laboratory and usually involves animal studies, the drug is subjected to clinical testing. This last step usually involves three phases.
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