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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
1 {8 `' C, _. n/ rDiabetes Mellitus — Evaluating Cardiovascular Risk in New
) J8 ^9 \% h+ z( r; [4 ^Antidiabetic Therapies to & v: K& j5 _9 z- @9 v
Treat Type 2 Diabetes
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/ R* k' a) O& m5 d# Q3 ]& R+ G, L' x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：" n$ P( q% d, [6 J% F' M
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I. INTRODUCTION
2 f& S) e# q/ F) z; V; d5 G( O0 u5 wThis guidance provides recommendations for the development of drugs and therapeutic biologics 8 @/ F# ^/ _) B. V+ ^, y% t4 t& D
regulated within the Center for Drug Evaluation and Research at the Food and Drug 2 z# H- Y9 G7 Y- g B) R7 X2 H
Administration (FDA) for the treatment of diabetes mellitus.20 {: I1 V7 u" e5 Z+ Q
Specifically, this guidance makes . E9 O% U, `1 b
recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2
, t; I3 f- z' t0 Rdiabetes is not associated with an unacceptable increase in cardiovascular risk.
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I 介绍! n0 r8 ~8 R7 I0 A, M+ I4 u
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。
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II. BACKGROUND
0 i4 C$ m8 r5 R% B' b0 w bDiabetes mellitus has reached epidemic proportions in the United States and more recently
9 l7 i5 t5 G% V& U* vworldwide. The morbidity and mortality associated with diabetes is anticipated to account for a 4 R, R; O1 |- D/ J0 z: W2 C
substantial proportion of health care expenditures. Although several drug treatments currently - c' R4 f4 R8 Q5 t- K
are available, we recognize the need for new agents for the prevention and treatment of diabetes
7 a: I( s4 L1 o+ @! c3 M6 u(e.g., development of drugs and therapeutic biologics).
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5 F1 q7 y0 \# J, T6 q D! `" |II 背景8 c1 I2 S6 H8 u
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）。8 ~; H- E- l' N% p- g2 n2 G
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发表于 2013-11-22 11:25:59
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发表于 2013-11-22 23:06:17
