clinical trial I

2018-08-03 · 첨삭 강사 Gray

학생이 쓴 원문

I understand you are eager to test the efficacy of your substance as early as possible. Pf. Kang gave me some advice and I searched further information for you. Clinical trial regulation law in Korea seems as strict as that in Canada and US. To proceed clinical trials in the institution in Korea, we need to do Investigational new drug (IND) application first since this is a brand new substance. Investigational new drug (IND) application is a bit difficult comparing with getting a new clinical indication with an existing drug such as rapamycin. We have lots of clinical trial experience to get a new clinical indication of existing drugs and to get the approval of KFDA with various medical devices. However, IND application process is beyond our clinicians’ ability. Most procedure related to IND process is done by cooperation between a drug company and clinical pharmacologists. IND application requires preclinical proof of concept study to prove its efficacy and safety.

강사 첨삭

I understand you are eager to test the efficacy of your substance as early as possible.

>> I understand that you are eager to test the efficiency of your substance as early as possible.

Pf. Kang gave me some advice and I searched further information for you.

>> Professor Kang gave me some advice and I searched for more further information for you.

Clinical trial regulation law in Korea seems as strict as that in Canada and US.

>> The clinical trial regulation law in Korea seems as strict as that in Canada and the US.

To proceed clinical trials in the institution in Korea, we need to do Investigational new drug (IND) application first since this is a brand new substance.

>> To process clinical trails in the institution in Korea, we need to do an Investigational new drug (IND) application first since this is a brand new substance.

Investigational new drug (IND) application is a bit difficult comparing with getting a new clinical indication with an existing drug such as rapamycin.

>> The investigational new drug (IND) application is a bit difficult comparing with getting a new clinical indication with an existing drug such as Rapamycin.

We have lots of clinical trial experience to get a new clinical indication of existing drugs and to get the approval of KFDA with various medical devices.

>> We have lots of clinical trial experiences to get a new clinical indication of existing drugs an to get the approval of KFDA with some various medical devices.

However, IND application process is beyond our clinicians’ ability.

>> However, The IND application process is beyond our clinician\'s ability.

Most procedure related to IND process is done by cooperation between a drug company and clinical pharmacologists.

>> Most of the procedure that are related to the IND process is done by the cooperation between a drug company and the clinical Pharmacologists.

IND application requires preclinical proof of concept study to prove its efficacy and safety.

>> The IND application requires preclinical proof of concept study to prove its efficacy and safety.

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