回复 克 飞
if you don't know, please do not pretend you are the expert.
Clinical Study takes more than 10 years to determine the medication's safety, effectiveness, dosage, side effect,........ it's divided in the following process:
1. pre-clinical study : 3.8 years study on average
purpose: Assess safety and biological activity in the lab and animal models
2. Clinical Study: Phase one, phase two and phase three, on average 10.4 years for each new medication.
Phase One: Determine what dosage will be safe and how treatment will be given.
Phase Two: Evaluate effectiveness and look for side effect
Phase Three: Determine whether the new treatment is better alternative to the current treatment
All clinical study will be use from healthy volunteers, sick people, start from small population and scale up to the huge population from phase 1 - 3
3. post -marketing study (post clinical trial) 1.5 -3 years depends on the nature of medication.
During this phase, follow individuals who taking this drug to look for side effect / adverse reaction which may not be show up during the clinical study.
There are lots of updates about the clinical study in the recent years.
路平平 发表于 2014-9-18 10:00 http://bbs.51.ca/images/common/back.gif
从PD(药物设计)的化学分子式设计, 到PK(药物动力学)的剂量的确定和给药周期确定, 我都做过.
前期的动物试验其它就是毒性(生命毒性, 即死亡)试验.。。对后面的给药剂量确定有帮助
出药前没有什么副作用的认证的.。。只可能为了证明该药比前面的药好, 对某种想要替代的药的某个致命副作用作一个比较, 其它新的副作用是未知的. |