| 24小時(shí)熱門(mén)版塊排行榜 |
| 1 | 1/1 | 返回列表 |
| 查看: 510 | 回復(fù): 0 | |||
[交流]
FDA仿制藥辦公室OGD在機(jī)制性口服吸收建模與模擬的經(jīng)驗(yàn)和成就-Xinyuan Zhang@FDA
|
|
FDA仿制藥辦公室OGD在機(jī)制性口服吸收建模與模擬的經(jīng)驗(yàn)和成就-Xinyuan Zhang@FDA OGD Experience and Efforts on Oral Absorption Modeling and Simulation FDA仿制藥辦公室OGD在機(jī)制性口服吸收建模與模擬的經(jīng)驗(yàn)和成就 Xinyuan(Susie) Zhang Office of Generic Drugs 導(dǎo)讀: 5月19日,美國(guó)FDA仿制藥部OGD舉辦“口服建模與模擬在制劑開(kāi)發(fā)與BE評(píng)價(jià)應(yīng)用培訓(xùn)班”, FDA仿制藥辦公室Xinyuan Zhang博士闡述了OGD在機(jī)制性口服吸收建模與模擬的經(jīng)驗(yàn)和成就。 Xinyuan Zhang博士分享了: 1)仿制藥辦公室OGD在吸收模型建模與模擬的進(jìn)展 2)應(yīng)用案例 -Evaluate the impact of slow dissolution in a specific pH condition on BE (warfarin sodium tablets) -Evaluate the PPI impact on BE (prasugrel HCl tablets, fingolimod capsules) 3)GDUFA 基金對(duì)提高口服吸收模型的建模與模擬的影響 總結(jié): 1)OGD已經(jīng)將基于機(jī)制吸收模型的建模與模擬納入到常規(guī)的法規(guī)監(jiān)管活動(dòng)中 2)OGD正積極地改善固體口服制劑預(yù)測(cè)科學(xué) 3)OGD愿意與內(nèi)部和外部利益相關(guān)者合作,在藥物產(chǎn)品開(kāi)發(fā)和管理評(píng)審中促進(jìn)機(jī)制性吸收模型的建模和模擬的應(yīng)用。 Xinyuan Zhang 博士的部分相關(guān)文章及Poster 1)Modeling and Simulation of Biopharmaceutical Performance 2)The role of predictive biopharmaceutical modeling and simulation in drug development and regulatory evaluation 3)Utility of Physiologically Based Absorption Modeling in Implementing Qualityby Design in Drug Development 4)Application of Physiologically Based Absorption Modeling forAmphetamine Salts Drug Products in Generic Drug Evaluation 5)Physiologically Based Absorption Modeling to Study Food Effects for a BCS II Drug 6)Computational Simulation aided Bioequivalence Study Design for an Antiepileptic Drug 下載原文件請(qǐng)點(diǎn)擊鏈接:http://pan.baidu.com/s/1miGodg0#rd |
| 1 | 1/1 | 返回列表 |
| 最具人氣熱帖推薦 [查看全部] | 作者 | 回/看 | 最后發(fā)表 | |
|---|---|---|---|---|
|
[考博] 環(huán)境領(lǐng)域全國(guó)重點(diǎn)實(shí)驗(yàn)室招收博士1-2名 +3 | QGZDSYS 2026-03-13 | 3/150 |
|
|---|---|---|---|---|
|
[考研] 268求調(diào)劑 +3 | 簡(jiǎn)單點(diǎn)0 2026-03-17 | 3/150 |
|
|
[考研] 268求調(diào)劑 +7 | 好運(yùn)連綿不絕 2026-03-12 | 8/400 |
|
|
[考研] 考研化學(xué)學(xué)碩調(diào)劑,一志愿985 +4 | 張vvvv 2026-03-15 | 6/300 |
|
|
[考研] 290求調(diào)劑 +6 | 孔志浩 2026-03-12 | 11/550 |
|
|
[考研] 289求調(diào)劑 +6 | 步川酷紫123 2026-03-11 | 6/300 |
|
|
[考研] 285化工學(xué)碩求調(diào)劑(081700) +9 | 柴郡貓_ 2026-03-12 | 9/450 |
|
|
[考研] 333求調(diào)劑 +3 | 文思客 2026-03-16 | 7/350 |
|
|
[考研] 化學(xué)調(diào)劑0703 +8 | 啊我我的 2026-03-11 | 8/400 |
|
|
[基金申請(qǐng)]
今年的國(guó)基金是打分制嗎?
50+3
|
zhanghaozhu 2026-03-14 | 3/150 |
|
|
[考研] 304求調(diào)劑 +4 | ahbd 2026-03-14 | 4/200 |
|
|
[考研] 085600材料與化工 求調(diào)劑 +13 | enenenhui 2026-03-13 | 14/700 |
|
|
[考研] 328求調(diào)劑 +3 | 5201314Lsy! 2026-03-13 | 6/300 |
|
|
[考研] 304求調(diào)劑 +6 | Mochaaaa 2026-03-12 | 7/350 |
|
|
[考研] 336求調(diào)劑 +6 | Iuruoh 2026-03-11 | 6/300 |
|
|
[考研] 求材料調(diào)劑 +5 | 隔壁陳先生 2026-03-12 | 5/250 |
|
|
[考研] 四川大學(xué)085601材料工程專碩 初試294求調(diào)劑 +4 | 祝我們好在冬天 2026-03-11 | 4/200 |
|
|
[考研] 333求調(diào)劑 +3 | 球球古力 2026-03-11 | 3/150 |
|
|
[考研] 290求調(diào)劑 +3 | ADT 2026-03-13 | 3/150 |
|
|
[考博] 26讀博 +4 | Rui135246 2026-03-12 | 10/500 |
|