大多数儿童药都在成人身上试的。因为试药是有经济补偿的,所以会很谨慎不在儿童身上试因为否则大多数被试都是穷人家的孩子。

来源: Kamioka 2012-08-31 12:14:45 [] [博客] [旧帖] [给我悄悄话] 本文已被阅读: 次 (1631 bytes)
回答: 如果是儿童新药呢?老忽叔叔2012-08-31 11:29:44

大多数儿童药都在成人身上试的。因为试药是有经济补偿的,所以会很谨慎不在儿童身上试因为否则大多数被试都是穷人家的孩子。08年开始有部分放开,引起极大争议。有儿童的实验都是谨慎又谨慎,因为要求不单benefit outweight harm,而且几乎要求是no harm的。

FROM FDA: (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164427.htm)

Q: Are medications that are intended for children clinically tested on children?

 

A: If the product is to be used only for children, then it must be studied in the pediatric population. However, many therapies are developed for adults and then used in children without having been studied in children. Therefore, most marketed products that are mostly used in adults have not been studied in children—even though they may be used by doctors to treat children.

 

There has been improvement in this area in regard to prescription drugs. As of 2008, an estimated 50 to 60 percent of prescription drugs used to treat children have been studied in some part of the pediatric population. Still, the likelihood that a medicine has actually been studied in neonates—children less than a month old—is close to zero.

 

So nearly a decade into the 21st Century, most medicines intended for children, including many over-the-counter (OTC) products, haven’t been clinically studied in children—and certainly not in all age populations that comprise the branch of medicine known as “pediatrics.”

所有跟帖: 

It has been tested by adults: -Morning3evening4- 给 Morning3evening4 发送悄悄话 Morning3evening4 的博客首页 (156 bytes) () 08/31/2012 postreply 12:25:10

yes, but testing that in children will never get approved in US. -Kamioka- 给 Kamioka 发送悄悄话 Kamioka 的博客首页 (0 bytes) () 08/31/2012 postreply 12:35:39

So they did it in China. As long as Chinese law is ok. -Morning3evening4- 给 Morning3evening4 发送悄悄话 Morning3evening4 的博客首页 (140 bytes) () 08/31/2012 postreply 12:38:28

如果是美国sponsor的实验的话要学校IRB通过的,即使是在国外做的实验,用的也是美国human subject的标准,否则资 -Kamioka- 给 Kamioka 发送悄悄话 Kamioka 的博客首页 (341 bytes) () 08/31/2012 postreply 12:45:45

我的理解有点不一样。 -Morning3evening4- 给 Morning3evening4 发送悄悄话 Morning3evening4 的博客首页 (119 bytes) () 08/31/2012 postreply 12:53:45

嘿嘿,如果是政府资助的,农业部可能性大的。 -Morning3evening4- 给 Morning3evening4 发送悄悄话 Morning3evening4 的博客首页 (277 bytes) () 08/31/2012 postreply 13:10:12

公司和农业部都是小来来,占极小比例。这种project随随便便都至少要一两千万的房顶,公司和农业部一般给个100万了不得了买个仪 -Kamioka- 给 Kamioka 发送悄悄话 Kamioka 的博客首页 (210 bytes) () 08/31/2012 postreply 13:14:01

文中说是NIH和农业部一起资助的。 -Kamioka- 给 Kamioka 发送悄悄话 Kamioka 的博客首页 (0 bytes) () 08/31/2012 postreply 13:48:39

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