 |
 |
 |
 |
 |
 |
||
 |
 |
 |
 |
 |
| 5 | 1/1 | 返回列表 |
| 查看: 1398 | 回復(fù): 4 | |||
| 當(dāng)前只顯示滿足指定條件的回帖，點(diǎn)擊這里查看本話題的所有回帖 | |||
liuyuwei1989新蟲 (初入文壇)
|
[交流]
FDA會(huì)認(rèn)可中國做的數(shù)據(jù)嗎 已有4人參與
|
||
|
在國內(nèi)做抗腫瘤活性測試(如 國家新藥篩選中心)后, 將來美國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)等在國內(nèi)做, 將來美國FDA會(huì)認(rèn)可這些數(shù)據(jù)嗎? |
回復(fù)此樓» 猜你喜歡
求助《生物利用度和生物等效性研究指導(dǎo)原則》（試 行），2002
已經(jīng)有0人回復(fù)
-
如何高效的測量腺病毒的粒徑和電位
已經(jīng)有0人回復(fù)
-
藥物學(xué)論文潤色/翻譯怎么收費(fèi)?
已經(jīng)有176人回復(fù)
-
文獻(xiàn)求助
已經(jīng)有0人回復(fù)
-
關(guān)于SCI雜志發(fā)表掛名
已經(jīng)有32人回復(fù)
-
26在職申博—生物與醫(yī)藥—抗體/ADC藥物方向，江浙滬，有項(xiàng)目，可帶資。
已經(jīng)有1人回復(fù)
-
288分求調(diào)劑
已經(jīng)有0人回復(fù)
-
一志愿蘇州大學(xué) 生物技術(shù)與工程（086001） 初試323分，求調(diào)劑
已經(jīng)有0人回復(fù)
-
三年實(shí)驗(yàn)室工作經(jīng)歷，一志愿華中農(nóng)業(yè)大學(xué)微生物，總分288求調(diào)劑
已經(jīng)有0人回復(fù)
» 本主題相關(guān)價(jià)值貼推薦，對您同樣有幫助:
- FDA中的AERs數(shù)據(jù)庫
已經(jīng)有5人回復(fù)
- 請問EIS阻抗數(shù)據(jù)用辰華的660測試，國際期刊認(rèn)可這個(gè)儀器的結(jié)果嗎？
已經(jīng)有4人回復(fù)
★ ★
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
|
說說美國人的思維，美國人既是辦事認(rèn)真又是態(tài)度靈活的一群人。至于美國人認(rèn)不認(rèn)中國的數(shù)據(jù)，要看中國自己的情況了。 舉個(gè)例子，美國FDA的官員來中國審核某企業(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，從這點(diǎn)上來說是很嚴(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明問題就OK。 中國人辦事的一個(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
muziqian38
鐵蟲 (初入文壇)
- 應(yīng)助: 0 (幼兒園)
- 金幣: 61.7
- 帖子: 14
- 在線: 2小時(shí)
- 蟲號(hào): 1237577
- 注冊: 2011-03-18
- 性別: MM
- 專業(yè): 藥物化學(xué)
★ ★ ★ ★
小木蟲: 金幣+0.5, 給個(gè)紅包，謝謝回帖
癡夷子皮: 金幣+3, 熱心獎(jiǎng)勵(lì) 2012-09-25 08:16:47
小木蟲: 金幣+0.5, 給個(gè)紅包，謝謝回帖
癡夷子皮: 金幣+3, 熱心獎(jiǎng)勵(lì) 2012-09-25 08:16:47
|
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，說美國FDA認(rèn)可了一個(gè)治療肝炎的藥物在中國做的臨床試驗(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。希望對你有幫助。 美國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
yaowushuo
捐助貴賓 (小有名氣)
- 應(yīng)助: 2 (幼兒園)
- 金幣: 474.9
- 帖子: 124
- 在線: 17.6小時(shí)
- 蟲號(hào): 233678
- 注冊: 2006-03-30
- 性別: GG
- 專業(yè): 藥物化學(xué)
★ ★ ★ ★
小木蟲: 金幣+0.5, 給個(gè)紅包，謝謝回帖
zhychen2008: 金幣+3, 感謝回帖交流 2012-10-07 16:42:15
小木蟲: 金幣+0.5, 給個(gè)紅包，謝謝回帖
zhychen2008: 金幣+3, 感謝回帖交流 2012-10-07 16:42:15
|
新藥研發(fā) 會(huì)認(rèn)可的，美國上臨床的化合物是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)國內(nèi)SFDA更低 藥效評價(jià) sponser自己負(fù)責(zé) 毒性評價(jià) 要求高一些，最好找一個(gè)CRO公司，他們有報(bào)美國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)可國內(nèi)數(shù)據(jù)，但是到國外還是要重新做的啊  |
5樓2012-10-06 17:33:17
| 最具人氣熱帖推薦 [查看全部] | 作者 | 回/看 | 最后發(fā)表 | |
|---|---|---|---|---|
|
[考研] 085601調(diào)劑 358分 +3 | zzzzggh 2026-03-20 | 4/200 |
|
|---|---|---|---|---|
|
[考研] 一志愿天津大學(xué)化學(xué)工藝專業(yè)（081702）315分求調(diào)劑 +12 | yangfz 2026-03-17 | 12/600 |
|
|
|
[考研] 328求調(diào)劑，英語六級551，有科研經(jīng)歷 +4 | 生物工程調(diào)劑 2026-03-17 | 8/400 |
|
|
|
[考研] 324分 085600材料化工求調(diào)劑 +4 | llllkkkhh 2026-03-18 | 4/200 |
|
|
|
[考研] 一志愿西南交大，求調(diào)劑 +5 | 材化逐夢人 2026-03-18 | 5/250 |
|
|
|
[考研] 材料專業(yè)求調(diào)劑 +6 | hanamiko 2026-03-18 | 6/300 |
|
|
|
[考研] 274求調(diào)劑 +10 | S.H1 2026-03-18 | 10/500 |
|
|
|
[考研] 一志愿 西北大學(xué) ，070300化學(xué)學(xué)碩，總分287，雙非一本，求調(diào)劑。 +4 | 晨昏線與星海 2026-03-19 | 4/200 |
|
|
|
[考研] 350求調(diào)劑 +5 | weudhdk 2026-03-19 | 5/250 |
|
|
|
[考研] 一志愿中南化學(xué)（0703）總分337求調(diào)劑 +8 | niko- 2026-03-19 | 9/450 |
|
|
|
[考研] 290求調(diào)劑 +7 | ^O^乜 2026-03-19 | 7/350 |
|
|
|
[考研] 一志愿西南交通 專碩 材料355 本科雙非 求調(diào)劑 +5 | 西南交通專材355 2026-03-19 | 5/250 |
|
|
|
[基金申請]
學(xué)校已經(jīng)提交到NSFC，還能修改嗎？
 40+4
|
babangida 2026-03-19 | 8/400 |
|
|
|
[考研] 招收調(diào)劑碩士 +4 | lidianxing 2026-03-19 | 12/600 |
|
|
|
[考研] 一志愿中國海洋大學(xué)，生物學(xué)，301分，求調(diào)劑 +5 | 1孫悟空 2026-03-17 | 6/300 |
|
|
|
[考研] 材料，紡織，生物（0856、0710），化學(xué)招生啦 +3 | Eember. 2026-03-17 | 9/450 |
|
|
|
[考研] 290求調(diào)劑 +3 | p asserby. 2026-03-15 | 4/200 |
|
|
|
[考研] 一志愿南京大學(xué)，080500材料科學(xué)與工程，調(diào)劑 +4 | Jy? 2026-03-16 | 4/200 |
|
|
|
[考研] [導(dǎo)師推薦]西南科技大學(xué)國防/材料導(dǎo)師推薦 +3 | 尖角小荷 2026-03-16 | 6/300 |
|
|
|
[考研] 一志愿211 0703方向310分求調(diào)劑 +3 | 努力奮斗112 2026-03-15 | 3/150 |
|