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FDAÁ{§ÉªvÀø²×ÂI«ü¾Éì«h: 2017¦~FDA¨î©wMultiple Endpoints in Clinical Trials Guidance for Industry¡A «ÂI¦b±±¨îÁ{§É¸ÕÅ窺¥Dn«ü¼Ð©M¦¸n«ü¼ÐªºType I Error, Type II Error, and p-value ! «ÂI¦b±±¨îÁ{§É¸ÕÅ窺¥Dn«ü¼Ð©M¦¸n«ü¼ÐªºType I Error, Type II Error, and p-value ! 1.FDA Multiple Endpoints in Clinical Trials Guidance for Industry www.fda.gov/files/drugs/published/Multiple-Endpoints-in-Clinical-Trials-Guidance-for- Industry.pdf 2.°]¹Îªk¤HÂåÃÄ«~¬dÅ礤¤ß¦ÒFDA¨î©w¤§ Draft Guidance for Industry: Multiple Endpoints in Clinical Trials (2017)¨î©w¡uÁ{§É¸ÕÅç¦h«ÀË©w¦Ò¶q¡v«ü¾Éì«h¡A§@¬°Á{§É¸ÕÅç³]p»P³W¹ºªº«n°Ñ¦Ò¨Ì¾Ú¡C www.cde.org.tw/Content/Files/Knowledge/%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97%E5%A4%9A%E9%87%8D%E6%8C%87%E6%A8%99%E4%B9%8B%E7%B5%B1%E8%A8%88%E6%8C%87%E5%B0%8E%E5%8E%9F%E5%89%87_%E7%AC%AC%E4%B8%80%E7%89%88.pdf ¦¸n«ü¼Ðªº¥¿¦Vµ²ªG¡A¶È¦³¦b¥Dn«ü¼Ð®a±ÚªºÀø®Ä¤w¸gÀò±oÃÒ©ú®É¤~¥i¸ÑŪ 3.¬ü°êFDA¡uÁ{§É¸ÕÅç¦h«µû¦ô«ü¼Ð«ü¤Þ¯ó®×¡v¤¤¤åª© www3.cde.org.tw/Content/Files/Knowledge/068bfcb1-e8d9-4b17-857e-13c08a3159a8.pdf |
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·|û¡GPeter Lin10152815 µoªí®É¶¡:2022/7/8 ¤U¤È 01:25:07²Ä 2207 ½g¦^À³
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·|û¡GPeter Lin10152815 µoªí®É¶¡:2022/7/8 ¤U¤È 01:15:03²Ä 2206 ½g¦^À³
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roger¥S. ¨ìF4¾ãÓ¨x³£Ãa±¼¤F§a¡A¤£¬O¦bF2-F3¦³¿ìªk±±¨î¤£¦bÄ~Äò´c¤Æ´N¦n¤F¶Ü? Phase3 Trials to support a marketing application Primary Endpoint: Resolution of steatohepatitis and no worsening of fibrosis. Improvement in fibrosis with no worsening of steatohepatitis. A co‐primary endpoint of the above or depending on the mode of action, either one or the other can be used. Target Population Patients with biopsy‐confirmed NASH with moderate/advanced fibrosis (F2/F3). |
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·|û¡GROGER588910148151 µoªí®É¶¡:2022/7/8 ¤U¤È 12:27:15²Ä 2205 ½g¦^À³
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·|û¡GROGER588910148151 µoªí®É¶¡:2022/7/8 ¤W¤È 09:36:36²Ä 2204 ½g¦^À³
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·|û¡GROGER588910148151 µoªí®É¶¡:2022/5/11 ¤W¤È 06:25:36²Ä 1967 ½g¦^À³ ¥Ó½ÐFDA pre-EUA meeting¡AFDA¦P·N»P§_±oªá¦h¤[? ¥un6Ó¤u§@¤Ñ!!! Veru contacted on MAY 2 about FDA willing to meet on EUA and granted meeting MAY 10, TODAY, only 6 (SIX) BUSINESS DAYS AFTER! ------------------------------------------------------------------------------------------------- ¤£¤NÃø¼B¸³¡A¯à»PFDA¶}pre-EUA meeting¾÷²v¡A©ú¤é°_ºâ1¤Ñ´î1%¡Aº¡¦Ê¤é«h¾÷²v¬°0¡C |
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·|û¡GROGER588910148151 µoªí®É¶¡:2022/7/8 ¤W¤È 09:12:21²Ä 2203 ½g¦^À³
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«ç»ò°h¨B¤F?¼Æ¾Ú©úÅ㤣¨Î¡A¬°¦óµwµÛÀY¥Ö¤]n¨«EUA¥Ó½Ð?(²ö«D©È¹¨¥³Q§i?) ------------------------------------------------------------------------------------------------- ·|û¡GROGER588910148151 µoªí®É¶¡:2022/6/16 ¤W¤È 07:42:26²Ä 2087 ½g¦^À³ Veru¥Ó½ÐEUA·Ó°_¤u3->4->5¡A°ê¹©¿W¨B¤Ñ¤U4->5¡C ------------------------------------------------------------------------------------------- ·|û¡GROGER588910148151 µoªí®É¶¡:2022/3/21 ¤W¤È 08:01:08²Ä 1807 ½g¦^À³ ... ³o¬OEUAªº¬yµ{7¨B¦±! ..Step 3: Pre-EUA Submission A pre-meeting will facilitate a rapid more complete EUA submission. Step 4: Submission of EUA This involves submitting an EUA request to be reviewed by the FDA. Step 5: Approve/Reject EUA After reviewing the EUA application, the FDA issues a formal approval or rejection. |
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·|û¡GROGER588910148151 µoªí®É¶¡:2022/7/8 ¤W¤È 09:01:59²Ä 2202 ½g¦^À³
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2022.7.7°ê¹©:°ê¹©¥Í§Þ´£¥æªºPre-EUA Meeting Request Submission(ºò«æ¨Ï¥Î±ÂÅv«e·|ij½Ð¨D)Àò¬ü°êFDA¥¿¦¡¦^ÂЦ¬®×! ½¥Õ¸Ü:°ê¹©°e¥X¤å¥ó¦VFDA¥Ó½Ð¶}ÓPre-EUA·|ij¡AµM«áFDAµoӤ帹¡A¦^»¡¦³¦¬¨ì±zªº¥Ó½Ð¡A¶È¦¹¦Ó¤w¡C(Ãļt»P¤½®a¾÷Ãö¤å®Ñ ¨Ó©¹³W«h) «ÂI¦bFDA¬Ý§¹¸ê®Æ«á¦P·N©Î¤£¦P·N±ÆÓPre-EUA Meeting¤é´Á¡A¸ò±z¶}·|!!! |
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·|û¡GROGER588910148151 µoªí®É¶¡:2022/7/7 ¤U¤È 05:10:38²Ä 2201 ½g¦^À³
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·|û¡GROGER588910148151 µoªí®É¶¡:2022/7/7 ¤W¤È 11:26:27²Ä 2199 ½g¦^À³ MGL-3745¼g¿ù§ï¥¿¦¨MGL-3196(Resmetirom)¡C 2022.7.5 ¤û¬z¤j¾Ç¨x¯f¾Ç«È®y±Ð±Â´µ¸¦ªâ«¢¨½´ËÂå¾Ç³Õ¤h: Resmetirom¡§¦³¥i¯à¦¨¬°²Ä¤@Ó³Q§åã¥Î©ó NASH ±wªÌªºÃĪ«¡¨ www.healio.com/news/gastroenterology/20220705/resmetirom-has-potential-to-be-first-medication-approved-for-patients-with-nash ------------------------------------------------------------------------------------------------- µ²½×: ³Õ¤h¨S»¡ªº¨Æ¡AResmetirom¬O§_¯u¯à¦¨¬°²Ä¤@Ó³Q§åã¥Î©ó NASH ±wªÌªºÃĪ«¡AÃöÁä¦b¦~©³ªºÅ]¤ýÃö¥d¨x¬ïµ²ªG¦p¦ó?(¤T´Á±on¨x¬ïLiver Biopsy) |
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MGL-3745¼g¿ù§ï¥¿¦¨MGL-3196(Resmetirom)¡C 2022.7.5 ¤û¬z¤j¾Ç¨x¯f¾Ç«È®y±Ð±Â´µ¸¦ªâ«¢¨½´ËÂå¾Ç³Õ¤h: Resmetirom¡§¦³¥i¯à¦¨¬°²Ä¤@Ó³Q§åã¥Î©ó NASH ±wªÌªºÃĪ«¡¨ www.healio.com/news/gastroenterology/20220705/resmetirom-has-potential-to-be-first-medication-approved-for-patients-with-nash ------------------------------------------------------------------------------------------------ ·|û¡GROGER588910148151 µoªí®É¶¡:2022/7/5 ¤U¤È 05:47:26²Ä 2190 ½g¦^À³ ¦pªGInterceptªºOcaliva¨S¹LÃö¨úÃÒ¡A©ú¦~·¥¥i¯à¥ÑMadrigalªºMGL-3745¹Ü»í? |
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§Q¥ÎDGAT1[ÄY«ªºG¸z°Æ§@¥Î-¸¡Âm]--§ïªvÀø«K¯µ±wªÌ!!! 1. 2022.6.8 (DGAT1) Pradigastat ¦b¥\¯à©Ê«K¯µ±wªÌ¤¤ªº·§©ÀÅçÃÒ¬ã¨s clinicaltrials.gov/ct2/show/NCT04620161?term=NCT04620161&draw=2&rank=1 2. 2019.2.18 ¤¥´I¬ã发ºÞ线¡I¦w济药业获±o诺华pradigastat±Â权 www.163.com/dy/article/E94HUUBM0530JPJ4.html ªñ¤é¡A¦w济药业¥¿¦¡从诺华¡]Novartis¡^¤½¥q¡]NYSE: NVS¡^获±o¤Fpradigastatªº±Â权¡A进¤@¨B¤¥´I¤F¦w济ªº产«~ºÞ线¡C Pradigastat¬O¤G酰°ò¥Ìªo酰°ò转²¾酶¡]DGAT1¡^ªº¤p¤À¤l§í¨î剂¡A¦¹«e¤w¦b¥N谢¯e¯f¤W开®i¤F临§ÉIII´Á试验¡C¦w济计¦E 将pradigastat应¥Î¤_ªv疗¤@个·sÓì应¯g¡A§Y将¦b¤¤国ûD动针对该·sÓì应¯gªº临§ÉII´Á·§©À验证¬ã¨s... -------------------------------------------------------------------------------------------- ·|û¡GROGER588910148151 µoªí®É¶¡:2021/2/7 ¤W¤È 10:00:40²Ä 751 ½g¦^À³ ´¿¬O¼öªùªºDGAT1¹vÂI¡A¦]¬°¤jÃļt»â¥ý¸s±µ³s±¾¦bÄY«ªºG¸z°Æ§@¥Î¡A¦]¦¹»{©w¦¨¤£¤FÃÄ¡A¯É¯É©ñ±óÂ੹¨ä¥L¹vÂI¡A¨S·Q¨ìÄ~SNP-810«á¡ASNP-610¦A¦¸¦¨¥\¸ó¶V¤@¹D¨ä¥L¤jÃļt¹L¤£¤Fªº[ÄY«ªºG¸z°Æ§@¥Î]»Ùê!!! ---------------------------------------------------------------------------------------------- ·|û¡GROGER588910148151 µoªí®É¶¡:2021/1/20 ¤W¤È 05:37:39²Ä 526 ½g¦^À³ SNP-610(CYP2E1 + DGAT1, ¥´2ÓÂI)¦b¤@´Á»P¤G´ÁÁ{§É¹êÅçÀ³¸Ó¬O¸ó¹LG¸z°Æ§@¥ÎªùÂe»Ùê¡A¦¨¥\¸ô¤W¦AÁÚªñ¤@¨B! (GSK / ¿ÕµØ/ªü´µ§Q±d/½÷·çªºDGAT1ÃĪ«¤À§O±¾¦bP1»PP2) |
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SNP-6¨t¦C¾AÀ³¯g°ª¥Ìªo¤Tà¦å¯g(HTG)? 1.SNP-6¨t¦C(DGAT1 + CYP2E1-->¿E¬¡FGF21)§¤¥ð®§°Ï(³æ¥´NASH) 2.VK1430 (DGAT1)´N¥´À»°ÏP1 (¥ª¥k¶}¤}NASH+HTG) www.vikingtherapeutics.com/pipeline/overview/ 3.BIO89-100(FGF21)´§¥X¥þÂS¥´(¥ª¥k¶}¤}NASH+HTG) -------------------------------------------------------------------------------------- ·|û¡GROGER588910148151 µoªí®É¶¡:2022/7/4 ¤U¤È 08:15:37²Ä 2187 ½g¦^À³ ÂùºÞ»ô¤UDGAT1(°§C¨xŦ¤T»Ä¥Ìªo¯×°ï¿n)+§í¨îCYP2E1¿E¬¡PPAR£\-FGF21¡A¯à»PBIO89-100(pegozafermin)¤@¸û°ª¤U? ---------------------------------------------------------------------------------------------- ·|û¡GROGER588910148151 µoªí®É¶¡:2022/2/27 ¤U¤È 03:53:49²Ä 1752 ½g¦^À³ NASHÁ{§ÉÃĪ«³Ì·s¸ê®Æ(SNP-630º²{) DGAT1 (1¤ä):VK1430(º²{) DGAT1+ CYP2E1: SNP-610»P SNP-630 |
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ROGER¥S §Ú¤£¬OªL¥_¤j¡A¤£¹Lª±ªÑ²¼¨ì³Ì«á¡A¥u¹ï·sÃĪѦ³¿³½ì¡A®³Ó500¸U¥X¨Ó½ä¤@¤UªYÄ£¡A¿ï¹ï¤@¦¸P´I¡A°]´I¦Û¥Ñ¡A¤p¿ú¡C ¥_·¥¬P§Ú¤]¦³¦b¬Ý¡A¤£¹L¥L¨ºÓ¥«³õ¦ôÈ¡A©l²×µLªk¦ô¡A¤£¾å±oROGER¥S«ç»ò¬Ý¡H ·sÃĪѦôȳ̫n¡A´N¹³ªÑ¥«¦P¾Ç·|¨ºÓº¡¤À¤j¡A2¦~¦hªÑÄÖ¡A¸£³U¤£¿ù¡Aª¾¹D¦ôȪº«n©Ê¡C °ò¥»¤W¡A§Ú¹ï¦ô¤£¥XȪº·sÃĪѩΪ̥«³õ¤p¨S¤°»ò»ùȪº·sÃĪѡA§Ú¤£·|¶i¤@¨B¬ã¨sÃĪº¾÷Âà¸òÄvª§ÃĪ«¡C ³oÃä¤j®a¤ñ¸û±M·~¤@ÂI¡A½Íªº¤ñ¸û²`¤J¡AÁÙ¤£¿ù¡C |
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