Clinical Trials
- 최초 등록일
- 2013.10.21
- 최종 저작일
- 2013.04
- 6페이지/ MS 워드
- 가격 1,000원
목차
Ⅰ. About Clinical Trial.
1. Definition of clinical trials
2. Reason of clinical trial
3. Purpose of clinical trials
Ⅱ. Phase of Clinical Trials
1. Phase 0 trials
2. PhaseⅠ trials
3. Phase Ⅱ trials
4. Phase Ⅲ trials
5. Phase Ⅳ trials
Ⅲ. Ethical problem of Clinical trial and ICH-GCP
본문내용
Ⅰ. About Clinical Trial.
1. Definition of clinical trials
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.
2. Reason of clinical trial
A clinical trial is one of the final stages of a long and careful disease research process. Studies are done with disease patients to find out whether promising approaches to disease prevention, diagnosis, and treatment are safe and effective.
<중 략>
In phase III b, when clinical trials show a new drug treatment is more effective and/or safer than the current standard treatment, a new drug application (NDA) is submitted to the KFDA for approval. The KFDA then reviews the results from the clinical trials and other relevant information. If the KFDA has questions, it may ask for more information or even require that more studies be done. This can extend the approval process to more than 5 years. Based on its review, the KFDA decides if the treatment is OK to be used in patients with the type of illness the drug was tested on. If it is, the new treatment often becomes the standard of care, and newer drugs must then be tested against it before being approved.
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