想要在登記人體藥物實驗之前除了要了解老媽自己的近況也要了解實驗進程

FDA美國食品藥物管理局藥物實驗進程 (翻譯的不好 請多指教)

進程一: 藥物的安全性:選一些人進行檢驗藥物劑量增加的對身體安全性與有效性到確定為止

During Phase I trials, a study team gives the treatment to a small number of volunteers and examines its action in the body, its safety, and its effects at various doses. Phase I trials generally last only a few months.

進程二 三 :藥物有效性:證明藥物是安全的就會開始正式臨床實驗 引進更多人,更長時間,定性定量來証明藥物有效性與安全性

-If results show that the treatment appears safe, it will be tested in Phase II and Phase III clinical trials. These trials involve larger numbers of people over longer periods of time. In these trials, the study team wants to know whether the treatment is safe and effective and what side effects it might have.

進程結束後 研究人員覺得治療有效且滿意 便可提出申請 FDA審核過資料報告後便決定是否可上市

After these phases are complete and investigators are satisfied that the treatment is safe and effective, the study team may submit its data to the Food and Drug Administration (FDA) for approval. The FDA reviews the data and decides whether to approve the drug or treatment for use in patients.