NURS 3100 Exam 1 Practice

A nurse is teaching a student nurse about the stages of drug approval. A drug manufacturer that is performing the effects of a drug on laboratory animals is in which phase of the new drug development timeline?

1. Clinical investigation

2. New drug application review

3. Postmarketing surveillance

4. Preclinical investigation

The correct answer is: Clinical investigation

In the new drug development timeline, the phase where a drug manufacturer is studying the effects of a drug on laboratory animals is known as the preclinical investigation phase. During this phase, the drug is tested in laboratory settings and on animals to assess safety, toxicity, and potential effectiveness before moving on to clinical trials involving human subjects. This phase is crucial in determining if the drug has the potential to be safe and effective for use in humans. Clinical investigation (Option A) takes place after the preclinical investigation phase and involves testing the drug on human subjects in controlled clinical trials to evaluate its safety and efficacy. New drug application review (Option B) is the phase where the drug manufacturer submits a comprehensive application to the regulatory agency seeking approval to market the drug. Postmarketing surveillance (Option C) occurs after the drug has been approved and is on the market. It involves monitoring the drug's safety and effectiveness in a larger population over an extended period.