Bulk Drugs Process Design, Technology Transfer, and First Manufacture

Technology Transfer of the Bulk Drug Process and First 

This chapter complements its preceding companion chapter 2, which addressed the task of bulk drug process development. The tasks addressed herein overlap the development of the process, as process design does, or culminate the development task, as technology transfer and first manufacture do. As in the previous chapter, this one seeks to provide a sound perspective of the latter tasks to the uninitiated and the 

chemical process design skills are hardly ever taught formally the Arst and last academic exposure most engineering students have to the subject is a rather superficial and highly structured process design project at the undergraduate level. To make matters worse, computer soft- 

The chapter also includes, in closing, some observations on the technologies of bulk drug processing—development as well as manufacture. While perhaps couched as pearls of wisdom, they reflect some of the deeply held views of the author that could help the new practitioner with a perspective of the bulk drug business enterprise. 

Broad brush definition of the task and its probable capital cost, venues and timetable. 

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Bulk Drugs Process Design Technology Transfer, and First Manufacture... 

The application of the fruits of bulk drug process development to process design, technology transfer, and first manufacture will be addressed in the companion chapter 3, as those... 

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