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Description The aim of the course is to provide attendees with a good basis to work from when involved in taking development candidates to the first in human trials with a view also on some longer-term requirements. The course content will therefore focus on the necessary early phases of chemical development as would typically be required to support production of up to about 2kg using laboratory-based 20L glassware. Course Content The course will introduce and discuss the following: * Requirements in order to move from small ( * Further scaling to 1-2kg non-cGMP * Requirements to make material for use in clinical trial - an introduction to cGMP coupled with the scaling issues * An overview of the requirements to move processes to fixed vessels, assuming cGMP is required * The phases of development and indicative timelines with quality requirements * The importance of physical form selection, understanding and control During the course, the lessons and the key learning opportunities are considered to be: * How long does it take to get from milligrams to 1-2kg suitable for human clinical trials? * What are the main hurdles? * What can be left out and what must be included? * What are the key project management considerations? Case studies and problem sessions will also be included throughout the course.

Description The aim of the course is to provide attendees with a good basis to work from when involved in taking development candidates to the first in human trials with a view also on some longer-term requirements. The course content will therefore focus on the necessary early phases of chemical development as would typically be required to support production of up to about 2kg using...

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