(Answered) Question 1 - for a new investigational drug product the

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Question 1 - For a new investigational drug product, the estimation of the first dose to be used in humans is usually derived from nonclinical studies. Please propose a nonclinical study design that would be conducted for the determination of the first-in-human dose for an investigational drug product.

Question 2 - Elaborate on the challenges associated with the use of animal models in nonclinical studies for the development of biologics products as compared to small molecule drug products

Question 3 - Discuss on the importance of phase IV clinical trials in the development of medicinal products for human use.

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