Clinical trial II
학생이 쓴 원문
강사 첨삭
Cooperation with clinical pharmacologists seems to be necessary in current situation, because they are professional in designing proof of concept studies.
>> The Cooperation with the clinical pharmacologists seems to be necessary in the current situation, because they are professionals in designing the proof of concept studies.
After getting approval of IND, we can move to phase I clinical trial to assess safety issue.
>> We can move to the phase one which is about the clinical trial to assess safety issue after getting the approval of IND.
Then, we can move to phase II clinical trial to assess the efficacy and establish the optimal concentration of the drug.
>> Then, we can move to the second phase, which is the clinical trial to assess the efficacy and establish the optimal concentration of the drug.
Phase III clinical trial is similar to phase II trial but needs larger number of patients. To save time, Phase I and Phase II studies are sometimes performed at the same time these days.
>> The third phase is the clinical trial that is similar to the second phase trial. But, it needs a larger number of patients. To save time, The first and second phase studies are sometimes performed at the same time these days.
To register the new substance into a medical device rather than a prescription drug would be much easier and less time-consuming.
>> COORECT
However, to register it as a prescription drug would be much valuable.
>> The value would be higher if the prescription drug would be registered.
Pf. Kang said that he can ask his collaborative clinical pharmacologist about this issue to give you more professional advice.
>> Pf. Kang said that he can ask his collaborative clinical pharmacologist about this issue to give you a more detailed professional advice.
In that case, the outline of your study and experimental results are needed to design a proof of concept study that is specific to your study.
>> In that case, the outline of your study and experimental results are needed to design a proof of concept study that is specific to your research.
I hope your discovery will pay off.
>> CORRECT
Please feel free to talk to me if you need further assistance.
>> CORRECT
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