Practice Quiz

FPGEE Foreign Pharmacy

Category - Pharmaceutical

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An IND (Investigational New Drug) application must contain which of the following information?

I. Pharmacological and toxicological studies in animal models
II. Information concerning the manufacture of a new drug
III. Information concerning proposed drug protocols
IV. Phase II clinical trial data
  1. I and II only
  2. I and IV only
  3. I, II, and III only
  4. III only
Explanation
Answer: C - An IND must contain the information listed in statements I, II, and III. IND applications are filed before any clinical trial is possible.
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