An application for a first-in-human clinical study for an in…
An application for a first-in-human clinical study for an investigational biologic includes limited in vitro data and preliminary animal studies, but key toxicology studies (including repeat-dose toxicity and safety pharmacology) are incomplete. In addition, the manufacturing process has not yet been fully validated, and there is insufficient information on product stability and impurity profiles. From a regulatory and ethical standpoint, which of the following is the most appropriate position?
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