'19.08.27, ̿Ǿ
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з ȭ(ѱ ҿ ) ڽ (()Ʈ۴ ̻) ľó Ż (ľó ) г
ø Ǵ γ, Ը, å Ȳ Ƿ, Ǵ ȼ(RFP) ݵ ȮϽñ ٶϴ.
̿IT÷ 19 , ƸƼ ̿Ǿǰ ű ̿, ٶϴ. Ǿǰ õ / ߴܰ Ǿǰ ǰ ߱ ȳ - . : ӻ (K-DREAM Program)
- . : ӻ ž R&D ȿ žళ ȯ
- . : ž ϰ ӻ ̿ó 8~18 ̳ IND û ȹ ִ
- . ûⰣ: 2019 8 22 () ~ 2019 9 04 ()
- . γ
- ICH E8(R1) ӻ Ϲ ̵() ǰ(~9/16) ٷΰ
/ 缺ٺ(簢) ʿ ? ٺ
ȿ , ߴ, , 뷮Ž, ٱ, 2 ӻ / 2 / ֽȸ / 2019-08-27 Ƽ縿(MTIG7192A), , ߷ / Ǵ ٹ ȯڸ Ƽ縿 ٶ , Ǵ
B- ȣŲ ȯڸ Ƽ縿 ø ൿ ϴ
1a/1b , ٱ ӻ / 1 / ڹݽڸƼȸ / 2019-08-23 GX-I7 / ܹ (pancreatic cancer) ȯڸ GX-I7 , Ȱ 븲(absolute lymphocyte count) ȭ ϱ , 2 ӻ / 2 / бΰ縯п 縯б Z / 2019-08-23 ƮŸ ߰ٱ⼼ / ġ 索 α˾ âġῡ ־ Ż Ʈ ġ ȿ ϱ , , Ȱ, ϱ, 1/2, ֵ ӻ / 1/2 / бǰм / 2019-08-21
Ga 68 DOTATOC NDA #210828 / Ga 68 DOTATOC / Ź / UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER (08/21/2019)
XENLETA NDA #211673 / LEFAMULIN ACETATE /
Ź /
NABRIVA THERAPEUTICS US INC (08/19/2019) XENLETA NDA #211672 /
LEFAMULIN ACETATE / Ź / NABRIVA THERAPEUTICS US INC (08/19/2019) FULVESTRANT NDA #210063 /
FULVESTRANT / Ǵ / TEVA PHARMS USA INC (08/19/2019) HELIUM, USP NDA #213727 / HELIUM / A G L WELDING SUPPLY CO INC (08/18/2019)
ؿ ӻ (clnicaltrials.gov 2019.08.13~2019.08.19)
<̱> NCT04053634 / Efficacy and
Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive
Pulmonary Disease (COPD) With a History of Frequent Exacerbations / Chronic
Obstructive Pulmonary Disease / Biological:
Benralizumab, Biological: Placebo /AstraZeneca / Phase 3
2019 AHC Workshop- 9 3(ȭ) - 4()
- ڿ ۷Ȧ 300ȣ
- AHC:
ƽþơ ü ȭ(Asia-Pacific Economic Cooperation Harmonization Center)
- ̿ ȭ о /п ǹ߽
- 10 10() - 11()
- (뱸) 3 ǽ
- ,
<Ÿ >- 2019 ICH ̵ , ư, 9 4() - 5() [Click]
- [-DIA] ICH Workshop, ư, 9 6() [Click]
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