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liuyuwei1989新蟲 (初入文壇)
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FDA會(huì)認(rèn)可中國(guó)做的數(shù)據(jù)嗎 已有4人參與
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在國(guó)內(nèi)做抗腫瘤活性測(cè)試(如 國(guó)家新藥篩選中心)后, 將來(lái)美國(guó)FDA會(huì)認(rèn)可這些數(shù)據(jù)嗎? 其它比如毒性試驗(yàn), 臨床試驗(yàn)等在國(guó)內(nèi)做, 將來(lái)美國(guó)FDA會(huì)認(rèn)可這些數(shù)據(jù)嗎? |
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muziqian38
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癡夷子皮: 金幣+3, 熱心獎(jiǎng)勵(lì) 2012-09-25 08:16:47
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癡夷子皮: 金幣+3, 熱心獎(jiǎng)勵(lì) 2012-09-25 08:16:47
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我?guī)湍惆俣攘艘幌�。有一個(gè)帖子和你類似。原文是 各位大俠，最近偶讀到一篇文章，說(shuō)美國(guó)FDA認(rèn)可了一個(gè)治療肝炎的藥物在中國(guó)做的臨床試驗(yàn)數(shù)據(jù)。本人未能查到出處，不知哪位知情可否告知。 其中有一個(gè)回帖。如下。希望對(duì)你有幫助。 美國(guó)FDA承認(rèn)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樓2012-09-24 17:32:15
3樓2012-09-25 13:05:06
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小木蟲: 金幣+0.5, 給個(gè)紅包，謝謝回帖
zhychen2008: 金幣+1, 感謝回帖交流 2012-10-07 16:41:29
小木蟲: 金幣+0.5, 給個(gè)紅包，謝謝回帖
zhychen2008: 金幣+1, 感謝回帖交流 2012-10-07 16:41:29
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說(shuō)說(shuō)美國(guó)人的思維，美國(guó)人既是辦事認(rèn)真又是態(tài)度靈活的一群人。至于美國(guó)人認(rèn)不認(rèn)中國(guó)的數(shù)據(jù)，要看中國(guó)自己的情況了。 舉個(gè)例子，美國(guó)FDA的官員來(lái)中國(guó)審核某企業(yè)的車間，要求出具相應(yīng)的SOP，并且審查得非常細(xì)致，還要當(dāng)面核對(duì)，從這點(diǎn)上來(lái)說(shuō)是很嚴(yán)格的。但科研又是另一種情況了，在硬件、軟件達(dá)標(biāo)的前提下，一些研究是沒有硬性規(guī)定的，只要你的研究能充分說(shuō)明問題就OK。 中國(guó)人辦事的一個(gè)典型思路就是領(lǐng)導(dǎo)要求的就是我必須辦理的，美國(guó)不是啊，F(xiàn)DA只是負(fù)責(zé)審核、配合申辦者的工作，申辦者具有很高的主動(dòng)權(quán)。要想獲得美國(guó)的認(rèn)可，首先應(yīng)贏得自己的認(rèn)可和專家的認(rèn)可。 |
4樓2012-09-25 13:16:24
yaowushuo
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zhychen2008: 金幣+3, 感謝回帖交流 2012-10-07 16:42:15
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zhychen2008: 金幣+3, 感謝回帖交流 2012-10-07 16:42:15
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新藥研發(fā) 會(huì)認(rèn)可的，美國(guó)上臨床的化合物是sponser自己負(fù)責(zé)，他審查一期臨床主要看你的毒性數(shù)據(jù)，符合他的要求，他不會(huì)太嚴(yán)格要求 API 藥學(xué)部分要求可能比報(bào)國(guó)內(nèi)SFDA更低 藥效評(píng)價(jià) sponser自己負(fù)責(zé) 毒性評(píng)價(jià) 要求高一些，最好找一個(gè)CRO公司，他們有報(bào)美國(guó)FDA的經(jīng)驗(yàn)，今后有什么問題，方便解決，回答 臨床 會(huì)認(rèn)可國(guó)內(nèi)數(shù)據(jù)，但是到國(guó)外還是要重新做的啊  |
5樓2012-10-06 17:33:17
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