(ľó) 2,482 Ǿǰ 㰡Ű 101 ǰ 㰡(114.8%) - Ǿǰ 㰡Ű Ȳ ֿ Ư¡
- - Ǿǰ 㰡 '17 ̾ ༼ - ȿδ Ű Ǿǰ
Ǿǰ 㰡 Ȳ - 2018 Ǿǰ 㰡 Ȳ(p64) : ¹Ǿǰ 3ǰ 36 ǰ
- 2018 㰡 Ȳ(p67~68) : ű 11 (,) 㰡
- 2018 Ǿǰ 㰡 Ȳ(p71~72) : ű 22 () 㰡
- ('12~'18) Ǿǰ 㰡 Ȳ(p73~74) : 㰡 1ǰ 21 () 㰡, 2018 2 7ǰ ű 㰡
㰡: ٺƮֻ25и(ȭɹĮ()) 2018 ű 㰡: Ʈʵø Ʈ(()ȭ) , ʵø(()ٴ) [ڷ 5] - ('01~'18) ġ 㰡 Ȳ (p75~76) : 15 () 㰡
Ǿǰý Ƿ ȯ ̽ ü ¶ ü: ü Ϻημ ǰ, üȸ ֿ Ͽ äϿ ̽ ִ , , ٸ, Ǻ, 縷, δ, , Ǹ, , Ű, ɳ ش : ̽ ü ä롤塤óԡ й ֵ 㰡 Ǿǰ õ / ߴܰ Ǿǰ ǰ ߱ ȳ - ѱʼǾǰ Ǿǰ аȸ Ȱ ÷ϰ ȳϿ 帮, Ǿǰ ȸ û/Ǹ Ź 帮ڽϴ.
- &̱ȸ(DIA) ũ ٷΰ
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ϽǾǰ , Ϻΰþ ǰȸ(~9/23) ٷΰ
- ICH E19 ȭ ̵() ǰ(~8/30) ٷΰ
- [Ǿǰۿر] 2019 Ǿǰ ڷ (~9/20) ٷΰ
- JNJ-73763989 / B ̷ ġῡ JNJ-73763989 /Ǵ JNJ-56136379 ϴ پ ȿ ϱ 2b , ٱ, / 2b / ()ѱἾ / 2019-08-19
WAKIXNDA #211150 / PITOLISANT / Ź / BIOPROJET PHARMA (08/14/2019) INREBICNDA #212327 / FEDRATINIB HYDROCHLORIDE / Ź / IMPACT BIOMEDICINES INC (08/16/2019) RINVOQNDA #211675 / UPADACITINIB / Ź / ABBVIE INC (08/16/2019) RozlytrekNDA #212726 /
Ź / GENENTECH INC (08/15/2019) ROZLYTREKNDA #212725 / ENTRECTINIB / Ź / GENENTECH INC (08/15/2019) PRETOMANIDNDA #212862 / PRETOMANID / Ź / THE GLOBAL ALLIANCE FOR TB DRUG DEV (08/14/2019)
Azacitidine Celgene / Azacitidine (02/AUG/2019) - Myelodysplastic Syndromes - Leukemia, Myelomonocytic, Chronic - Leukemia, Myeloid, Acute02/08/2019
ؿ ӻ (clnicaltrials.gov 2019.08.13~2019.08.19)
<̱> - NCT03346135/ Daratumumab After Stem Cell Transplant in Treating Patients With Multiple Myeloma / Plasma Cell Myeloma, Secondary Amyloidosis / Procedure: Autologous Hematopoietic Stem Cell Transplantation|Drug: Melphalan|Biological: Daratumumab|Other: Laboratory Biomarker Analysis / City of Hope Medical Center|Janssen, LP /Phase 2
2019 AHC Workshop- 9 3(ȭ) - 4()
- ڿ ۷Ȧ 300ȣ
- AHC:
ƽþơ ü ȭ(Asia-Pacific Economic Cooperation Harmonization Center)
<Ÿ >- ۷ιȼ ۼ PTȭ(Ƿ Թ), ѱǺη°߿, 8 28()-29() [Click]
- [-DIA] ICH Workshop, ư, 9 6() [Click]
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