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.

1. What are the preclinical research and approvals (regulatory and other) that are required prior to commencing human clinical trials? What are the safety and other requirements that need to be satisfied?

Explanation / Answer

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

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