'19.09.03, ̿Ǿ
ľó, Ǿǰ ߿ 2019 Ǿǰȭȸ(ICH) ̵ (ľó) 2019 ICH ̵ - : , ̿Ǿ Ǿǰ ICH ̵ ٽɺо
- Ͻ: 2019 9 4() - 5() *9 6() : DIA-NIFDS ICH Workshop
- : ư,
- ֿ
(9/4) ǰо : ̿Ǿǰ , ̷ (9/4) պо : ӻ , Ҽ (9/5) ȿо : ӻ , ӻ (9/5) о : , ฮ
KoBIA's comments- 2019 ICH ̵ () մϴ. - ڷ 켱 Դϴ. - ڷ (ǥڷ) Ȩ ٿεϽ ֽϴ. Ǿǰ 鿪 ̵ Ǿǰ ֽ ݿ (2019.07.31.) ε
Ǿǰ 鿪 ̵ ֿ Ǿǰ 鿪 ִ ε (ȯ ȯ / ǰ) 鿪 ӻ ü 鿪 Ȯ ( / ü / 븮̼) Ǿǰ ü Ư м 鿪 ӻ (ൿ / ȿ / 鿪 ) 鿪 α - η
- 鿪 ü - ü Ư м ȵǴ - 鿪 α
Ǿǰ (09/02)- Ǿǰ(ǥ1)
- ߴܰ Ǿǰ(ǥ2)
- Ǿǰ 濬
- 207 ָ(ֻ) - 258 ̻ø(ֻ)
˱ ȳ - ſ ùٸ
- ÷翣 () - BCG (ٿ)- ֿ䳻
- , , ñ - ̻ ó
̿IT÷ 19 , ƸƼ ̿Ǿǰ ű ̿, ٶϴ. '̿IT÷' ؿ ̿Ǿǰ (, , ̵ /) ϰ ִ ƮԴϴ. ű α - α Ʈ
Ʈ ( )
( )
߰߱ (ܱ⺸)
Ư (ſ뺸_)
űԴü (Ժ ؿܻ)
ų (ؿܼ Ư)
- 9 11() ѱ̿ȸ åºη ȸ
* åȰ ٸ
NOURIANZ NDA #022075 / ISTRADEFYLLINE /Ź /KYOWA KIRIN (08/27/2019) HARVONI NDA #212477 / LEDIPASVIR;SOFOSBUVIR / ſ뷮 / GILEAD SCIENCES INC (08/28/2019) SOVALDI NDA #212480 / SOFOSBUVIR /
ſ뷮 /
GILEAD SCIENCES INC(08/28/2019) RIOMET ER NDA #212595 /
METFORMIN HYDROCHLORIDE /
ſ뷮 /
SUN PHARM INDS LTD (08/29/2019)
ؿ ӻ (clinicaltrials.gov 2019.08.27~2019.09.02)
<̱> NCT04035005 / A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive / Multiple Sclerosis Multiple Sclerosis, Primary Progressive / Ocrelizumab, Placebo / Hoffmann-La Roche / Phase 3
2019 AHC Workshop- 9 3(ȭ) - 4()
- ڿ ۷Ȧ 300ȣ
- AHC:
ƽþơ ü ȭ(Asia-Pacific Economic Cooperation Harmonization Center)
SR & META Analysis ǹǽ ⺻- Ͻ : 9 30(), ѱǺη°߿ ǻ 9 2 ǽ
- ֿ䳻: ž Ƿ() ü ӻ (ٰŹȰħ(EBRM) META м ǽ(RevMan) )
- ̿ ȭ о /п ǹ߽
- 10 10() - 11()
- (뱸) 3 ǽ
- ,
# (KPMG) Pharma Outlook 2030 : From Evolution To Revolution [Click] # The Small Molecule Antibiotics Pipeline : 2014 - 2018 [Click] |
|
|