Match the following clinical trial phases with the most appropriate description: Question 11 options

Match the following clinical trial phases with the most appropriate description: Question 11 options: Studies to determine additional risks, benefits and optimal use (often post-market) First in human studies designed to determine metabolic and pharmacologic action of a drug Controlled trials in hundreds of subjects to determine short-term side effects and risks Controlled trials in thousands of subjects to analyze the overall risk/benefit ratioThis type of FDA application must be submitted in order to conduct a clinical trial in humans: Question 12 options: a) Investigational New Drug (IND) b) New Drug Application (NDA) c) Biologics License Application (BLA) d) Pre-Market Notification (510k)

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