A client has been selected as a participant in the approval process of a particular drug. The client's dose and any effects from the medication are being monitored. Which phase of drug approval is this client participating in?
1. Post-marketing study
2. Clinical phase trial
3. Postclinical investigation
4. Preclinical investigation
Correct Answer: 4
Rationale 1: Post-marketing studies take place after clinical trials to check for any new harmful effects in a larger and more diverse population.
Rationale 2: Clinical investigation is the second and longest part of the drug approval process, and takes place in three different phases, termed clinical phase trials. During this phase, clinical investigators address concerns such as whether the drug worsens other medical conditions; establish drug doses; and try to identify adverse effects.
Rationale 3: Postclinical investigation is not a phase of the approval process.
Rationale 4: Preclinical investigation involves basic science research.
Global Rationale: Preclinical investigation involves basic science research. Post-marketing studies take place after clinical trials to check for any new harmful effects in a larger and more diverse population. Clinical investigation is the second and longest part of the drug approval process, and takes place in three different phases, termed clinical phase trials. During this phase, clinical investigators address concerns such as whether the drug worsens other medical conditions; establish drug doses; and try to identify adverse effects. Postclinical investigation is not a phase of the approval process.
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