In what stage of the drug manufacturing process do studies get conducted on human, volunteer test subjects?
A) Preclinical studies
B) Clinical evaluation
C) Clinical trials
D) Regulatory filling
Answer: C
Explanation: A) Incorrect. In preclinical studies, studies are conducted on nonhuman subjects that provide information pertaining about how the body processes the drug and any potential side effects.
B) Incorrect. In clinical evaluations, documents are submitted to the FDA requesting approval to test the new product in a select group of people.
C) Correct. In clinical trials, FDA-approved studies are conducted on human, volunteer test subjects.
D) Incorrect. In regulatory filling, documents are submitted to the FDA requesting marketing approval.
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