You are involved in establishing a start-up company that has licensed a new chem

Question

You are involved in establishing a start-up company that has licensed a new chemical entity with potential as a treatment for moderate to severe asthma. You are assigned to the team responsible for development of this product, and required to take it through preclinical and clinical development.


2. Having satisfied these pre-clinical requirements you are ready to proceed to Phase I “first-into-man” studies. Discuss the key requirements for the Phase I study design. Discuss also the key aspects of Phase I study conduct including data collection, data analysis, and reporting requirements.

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You are involved in establishing a start-up company that has licensed a new chem

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