|
|
只花1分钟注册，更多海淘保健品信息等着你
您需要 登录 才可以下载或查看，没有帐号？立即注册
x
糖尿病-在新的降糖疗法治疗2型糖尿病评估心血管疾病风险2008年10月
" L6 D) y" g" b% ]3 BDiabetes Mellitus — Evaluating Cardiovascular Risk in New
3 L$ k* h) z0 k! h3 zAntidiabetic Therapies to
0 w* \7 l6 N2 D9 pTreat Type 2 Diabetes
+ T d0 j* U& Z# [+ y" M" j+ s7 Y" @
这个文件比较大，先翻译一段，有兴趣的TX可以下载自己去看看：. u$ g: J* }6 x
/ j2 ^0 O+ j: T/ qI. INTRODUCTION
* R/ w' x3 g; V$ B! hThis guidance provides recommendations for the development of drugs and therapeutic biologics & r" x. D/ i! }. ~7 k t- M6 C5 \
regulated within the Center for Drug Evaluation and Research at the Food and Drug
c- i2 `2 q5 a+ gAdministration (FDA) for the treatment of diabetes mellitus.2
W' b& t3 X& ]% v Specifically, this guidance makes " m/ a* N$ g% l. ]! n
recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
: v% O0 W" P2 K8 |: Z Xdiabetes is not associated with an unacceptable increase in cardiovascular risk.
- _- D5 F6 h4 A2 A) t0 w! e/ I$ [5 l6 y4 s. K/ c3 g. L/ M
I 介绍. | N; S& t7 l5 U+ m8 k* c' V8 }
本指导提供了FDA关于治疗糖尿病，在药物和治疗性生物制品的开发方面的一些建议。尤其本指导会对II型糖尿病人介绍一种新型的降糖治疗，对心血管方面不会有无法接收的风险提高。
; J9 W! x( i9 |+ }
# B1 S: w& D! r" VII. BACKGROUND & q& ?, Y* H" K- w/ w$ z
Diabetes mellitus has reached epidemic proportions in the United States and more recently
Y" j. c: i# b( }( |worldwide. The morbidity and mortality associated with diabetes is anticipated to account for a " N1 J h5 G2 J' [$ j& W" j! s
substantial proportion of health care expenditures. Although several drug treatments currently
4 H/ F& @& J0 s& ~are available, we recognize the need for new agents for the prevention and treatment of diabetes ; j# o& \4 X$ v
(e.g., development of drugs and therapeutic biologics). % c: M! D, i' V' ~
& \2 X* R2 m+ o" W2 u/ n. Z, PII 背景
) o9 b' l7 P5 e& F' @% l1 ?. ?在美国乃至全世界，糖尿病已经达到了流行病的程度。由糖尿病引发的发病率和死亡率，在医疗费用支出中已经占相当大的比例。虽然现在已经有很多的治疗药物，我们意识到需要新的药品来阻止和治疗糖尿病（如，药物和治疗性生物制品）。
9 P3 F, K" G9 E7 o' o
|
|
发表于 2013-11-22 11:25:59
收藏
分享
微信分享
楼主
发表于 2013-11-22 23:06:17
