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FDA会认可中国做的数据吗已有4人参与
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在国内做抗肿瘤活性测试(如 国家新药筛选中心)后, 将来美国FDA会认可这些数据吗? 其它比如毒性试验, 临床试验等在国内做, 将来美国FDA会认可这些数据吗? |
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小木虫: 金币+0.5, 给个红包，谢谢回帖
痴夷子皮: 金币+3, 热心奖励 2012-09-25 08:16:47
小木虫: 金币+0.5, 给个红包，谢谢回帖
痴夷子皮: 金币+3, 热心奖励 2012-09-25 08:16:47
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我帮你百度了一下。有一个帖子和你类似。原文是 各位大侠，最近偶读到一篇文章，说美国FDA认可了一个治疗肝炎的药物在中国做的临床试验数据。本人未能查到出处，不知哪位知情可否告知。 其中有一个回帖。如下。希望对你有帮助。 美国FDA承认的研究： Entecavir Is Superior to Epivir-HBV in Reducing HBV DNA Levels Among Patients with Chronic Hepatitis B By Ronald Baker, PhD There are currently 3 FDA-approved agents for the treatment of chronic hepatitis B: Epivir-HBV (GlaxoSmithKline), Intron A (Schering-Plough) and Hepsera (Gilead Sciences). A number of new agents are in development for the treatment of hepatitis B. Entecavir is a promising new experimental nucleoside analog drug from Bristol-Myers Squibb that has entered Phase III clinical trials for efficacy, the final stage of testing prior to FDA evaluation for approval as a prescription drug. Entecavir shows superior effectiveness compared to Epivir-HBV (lamivudine; 3TC) in reducing HBV DNA levels in patients with chronic HBV, according to results of a Phase II study published in the December issue of Gastroenterology. The 24-week randomized, double blind study was conducted in 169 patients with chronic hepatitis B. The multicenter study took place at sites in China, Malaysia, The Philippines, Belgium, Canada and the US. The safety and efficacy of entecavir at various doses (0.01 mg/day, 0.1 mg/day, or 0.5 mg/day orally) were compared with Epivir-HBV (100 mg/day orally). Patients with chronic HBV (hepatitis B "e" antigen [HBeAg]-positive and -negative) were evaluated for efficacy using the two treatments. Compared with Epivir-HBV, entecavir reduced HBV DNA by an additional 0.97 log (10) at the 0.1-mg/day dose and an additional 1.28 log (10) at the 0.5-mg/day dose (P < 0.0001). A clear dose-response relationship was observed for entecavir with the higher doses showing significantly greater HBV suppression. In patients treated with entecavir 0.5 mg/day, 83.7% had an HBV-DNA level below the lower limit of detection of the Quantiplex branched DNA (bDNA) assay (Bayer-Versant Diagnostics), compared with 57.5% treated with 100 mg/day lamivudine (P = 0.008). In both treatment arms, very few patients achieved HBeAg loss and/or seroconversion by week 22. More patients treated with the 0.1-mg/day and 0.5-mg/day doses of entecavir had normalization of alanine transaminase (ALT) levels at week 22 compared with lamivudine (P = not significant). Entecavir was well tolerated; most adverse events were mild to moderate, transient, and comparable in all study arms. The authors conclude, "This study showed that entecavir has potent antiviral activity against HBV at 0.1-mg/day and 0.5-mg/day doses, both of which were superior to lamivudine in chronically infected HBV patients." 1/03/03 Reference CL Lai and others. Entecavir is superior to lamivudine in reducing hepatitis B virus DNA in patients with chronic hepatitis B infection. Gastroenterology 2002 Dec; 123: 1831-1838. Entecavir at Two Low Doses Demonstrates Potent Anti-HBV Activity in Phase II Trial in China Entecavir (ETV) is a novel hepatitis B antiviral agent with potent selective activity against the hepatitis B virus (HBV). This is the first phase II trial conducted in China with entecavir. The purpose of this study is to determine the proportion of subjects in the ETV and placebo treatment groups who demonstrate an antiviral response at the end of the 28-day dosing period as measured by either a ?2 log10 reduction in HBV DNA by bDNA assay or undetectable HBV DNA by bDNA assay plus a ? 2 log10 reduction in HBV DNA by PCR assay. This is an ongoing study in Chinese adults with chronic hepatitis B infection (HBeAg-positive and -negative) with less than 12 weeks of prior anti-HBV nucleoside therapy. The study has four phases: (1) a randomized 28-day double-blind dosing phase of two doses of ETV (0.1 and 0.5 mg once daily) compared with placebo; (2) a 56-day post-dosing phase; (3) a 48-week open-label ETV 0.5 mg once daily dosing phase; and (4) a 24-week post open-label follow-up phase. Results from the 28-day double blind dosing phase and 56-day post-dosing phase are presented here. Study Results 216 patients were randomized (1:1:1) in the study and 212 patients received at least one dose of study medication. The majority of the subjects were male (74%), all were Asian, 96% were HBeAg-positive and the mean age was 30 years. The three treatment groups (ETV 0.1 mg, ETV 0.5 mg, placebo) were similar in terms of median baseline HBV DNA level by bDNA assay (3.18, 3.04, 3.08 MEq/mL, respectively) and median baseline ALT values (57.0, 59.5, 64.0 U/L). Entecavir 0.1 and 0.5 mg doses were superior to placebo for the primary endpoint of reducing HBV DNA levels at Day 28 (86%, 93%, 3%, respectively; p < 0.0001). The mean change from baseline in HBV DNA levels at Day 28 for the ETV 0.1 mg, 0.5 mg, and placebo groups as determined by bDNA assay were -2.51, -2.73, and -0.12 log10 MEq/mL, respectively. In the 56-day post-dosing phase, the ETV 0.5 mg dose was associated with greater viral suppression than the 0.1 mg dose. The most common clinical adverse events (> 5% incidence) were fatigue, somnolence, dizziness, insomnia and rhinitis. There were no meaningful differences between the entecavir and placebo groups in the incidence of adverse events on treatment. Conclusion Entecavir at both 0.1 and 0.5 mg doses demonstrated potent antiviral activity compared with placebo, as measured by reduction in HBV DNA viral load over a 28-day treatment period. Both the 0.1 and 0.5 mg doses of ETV administered once daily for 28 days were safe and well tolerated. 11/05/03 Reference G Yao and others. A PHASE II STUDY IN CHINA OF THE SAFETY & ANTIVIRAL ACTIVITY OF ENTECAVIR IN ADULTS WITH CHRONIC HEPATITIS B INFECTION. Abstract 1143 (poster). 54th Annual Meeting of the American Association for the Study of Liver Diseases. October 24-28, 2003. Boston, MA. http://www.hivandhepatitis.com/hep_b/news/entecavir.html |
2楼2012-09-24 17:32:15
3楼2012-09-25 13:05:06
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小木虫: 金币+0.5, 给个红包，谢谢回帖
zhychen2008: 金币+1, 感谢回帖交流 2012-10-07 16:41:29
小木虫: 金币+0.5, 给个红包，谢谢回帖
zhychen2008: 金币+1, 感谢回帖交流 2012-10-07 16:41:29
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说说美国人的思维，美国人既是办事认真又是态度灵活的一群人。至于美国人认不认中国的数据，要看中国自己的情况了。 举个例子，美国FDA的官员来中国审核某企业的车间，要求出具相应的SOP，并且审查得非常细致，还要当面核对，从这点上来说是很严格的。但科研又是另一种情况了，在硬件、软件达标的前提下，一些研究是没有硬性规定的，只要你的研究能充分说明问题就OK。 中国人办事的一个典型思路就是领导要求的就是我必须办理的，美国不是啊，FDA只是负责审核、配合申办者的工作，申办者具有很高的主动权。要想获得美国的认可，首先应赢得自己的认可和专家的认可。 |
4楼2012-09-25 13:16:24
yaowushuo
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5楼2012-10-06 17:33:17