臨床醫學時代決定藥品用法的方法。
法規[]
臨床試驗(人體試驗):要遵守臨床試驗優良操作規範[]
第一階段[]
- 對20~80名健康自願者給藥，以了解藥品在人體之吸收、分佈、代謝、排泄情形及安全性，
- 確定人體忍受之劑量範圍，及
- 可能引起的不良反應。
第二階段[]
- 選擇至少100~200位自願病患進行，以了解該藥品可能之療效，並了解藥品在患者體內之吸收、分佈、代謝、排泄之情況，確定治療劑量及其治療範圍。
第三階段[]
- 本階段在多重醫療中心或機構選擇足夠特定的患者，進一步確認藥品之療效，並藉由多數患者之治療，確定適應症，並偵測藥品禁忌、不良反應之發生情形，取得注意事項、藥品交互作用等之資料。
- 此時可以申請藥物查驗登記
第四階段(新藥監視期)[]
針對核准上市之新藥品，為更了解其使用情形，於上市後列入售後監視，以了解藥品之不良反應發生情形、發掘罕見之不良反應，或了解是否有其他新適應症。
考題[]
Before you swallow that pill prescribed from your doctors, have you ever wondered what sort of tests has been done to ensure it is good for you, or is it even safe? Currently, before drugs are sold to consumers, at least four phases of premarket studies are done by researchers.
The first study or phase one is usually an animal study if a close enough physiology is found in that animal to humans. The aim of giving the drug to animals is to protect the lives of humans as it is more ethically correct to save valuable human lives rather than prevent animal fatalities.
The next three phases include three clinical studies and only proceeds once the first phase is passed. In phase two, the most initial test on people is done on very few healthy volunteers to check that there are no severe side effects. Phase three is also known as an efficacy study (a study to see if there are any benefits and/or side effects) and is done on patients with disease. This number, however, is still kept very small – about 200 to 500 volunteers – to save resources and not waste volunteers’ time if the drug is not effective in treating their diseases.
Phase four includes extensive clinical trials on a greater number of patients (still volunteers) so that researchers can deduce that the drug actually works for all patients by ruling out random error.
Upon the completion of the above four phases, the drug is allowed to be sold and should be safe for widespread use.
例子[]
癌症免疫療法[]
- 如果癌症 治療無效可以參加日本和台灣的免疫療法臨床試驗 :卡斯柏的癌症免疫治療經驗分享、免疫療法