1.Describe the types of nonclinical data needed to determine whether an
investigational drug would be effective.
2.Explain why GLP compliance is essential for preclinical studies.
3.Describe the primary goals of GCP and explain their importance.
4.Describe the elements of informed consent.
5.Discuss the phases of clinical development; include the types/designs of
studies done in Phase I.
6.Describe the content and format of an IND application?
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