Q1. Discuss the importance of clinical trial in the development of medicinal products for human use. In your opinion, is there ever a set of circumstances that would warrant the administration of therapies to people/patients without prior approval from the Food and Drug Administration?
Q2. Discuss the different phases of clinical study as they relate to the development and life cycle management of medicinal products for human use. Using a medicinal product and a disease of your choice, provide examples of clinical endpoints that would be measured for each of the phases of clinical studies and elaborate on their use in clinical evaluation of medicinal products for human use?