Which of the following would be information provided during the phases of clinical trials? Select all that apply
a. Purity
b. Bioavailability
c. Potency
d. Efficacy
e. Safety
f. Toxicity
g. Therapeutic value
ANS: A, B, C, D, E, F
The clinical phase of product development extends from a sponsor's initial submission of the in-vestigational new drug (IND) application to begin testing a new drug in humans (i.e., clinical studies), to submission of a complete new drug application (NDA) or biologic license application (BLA) to the Food and Drug Administration (FDA) for marketing approval. The four phases of clinical trials are designed to provide information about a drug's purity, bioavailability, potency, efficacy, safety, and toxicity.
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