Question
Proof of concept” for a new drug is generally proven in which phase of a clinical trial
| A. |
Phase I
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| B. |
Phase II
|
| C. |
Phase III
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| D. |
Phase IV
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Show Answer
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Correct Answer � B
Explanation
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|
Answer B
Phase II is the stage of clinical trials where most of the new drugs will be administered for the first time in patients with the target disease. It is carried out in a small (50-500) group of patients to obtain “proof of concept” that the drug has the potential to treat the intended disease.
It also includes dose ranging studies with respect to efficacy. Therefore, phase II studies can be divided into
Phase IIa
- Proof of concept study: pharmacodynamics or biological activity is the primary endpoint
Phase IIb
- Dose ranging study: provide inputs for choosing the most appropriate dose for phase III studies
