Someone asks a nurse about a new drug that is in preclinical testing and wants to know why it cannot be used to treat a friend's illness. Which statement by the nurse is correct?
a. "A drug at this stage of development can be used only in patients with serious dis-ease."
b. "At this stage of drug development, the safety and usefulness of the medication is unknown."
c. "Clinical trials must be completed to make sure the drug is safe to use in humans."
d. "Until postmarketing surveillance data are available, the drug cannot be used."
B
Preclinical testing must be completed before drugs can be tested in humans. In this stage, drugs are evaluated for toxicities, pharmacokinetic properties, and potentially useful effects. Some drugs can be used in patients before completion of Phase III studies, but this is after preclinical testing is complete. Clinical trials proceed in stages, and each stage has guidelines defining how a new drug may be used and which patients may receive it. Postmarketing surveillance takes place after a drug is in general use.
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