ȯ ġȸ Ȯ žళ ӻ ε ! ľó, ȯھ 'ӻ 5 հȹ' (ľó) ӻ ۷ι ȭ ȯ ߽ žళ 3 - ͳġȯ ġȸ Ȯ ӻ ͺȣ, žళ 3 21 ΰ ӻ 5 հȹ Ͽ
- () ӻ ü Ȯ
- () ӻ ȭ
- () ȯ ġȸ Ȯ ü
() ӻ ü - ӻ迡 Ǵ Ǿǰ ⺸ ǹȭ
- İ ü : 赵 ӻ ӻǽñ ǰ Ư ȭ
赵 ӻ: ( ) ӻ ڿ , ۿ ټ, ʰ ž - ߾ӻɻȸ ̼
߾ӻɻȸ: ӻ Źɻ, Ƿ ɻȸ ڹ ̼: ϴ ȯ ӻ , , ȫ
- ӻ üм(Central Lab) : ƽþ üм ġ
() ӻ ȭ - ܰ : Ȯ ӻ ӻ ʼ Ͽ ӻ
켱 Դ: ֿ 3 ٱ ӻ - ӻ Ͽ ŷڼ Ȯ , OECD ӻڷ
- ǰ κ , ӻȹ '' '' ȯ
- : 5ϳ ڷ ϰἺ Ȯ
- ӻ ɻ TF : ӻɻ ż
- ӻ(RWD)-ӻݱٰ(RWE) Ȱ (19.10 㰡 )
- ӻ ߡ('19~)
- ɻ ȭ ɻ η Ȯ('19~)
() ȯ ġȸ Ȯ ü - ý ࡤ : ȯڿ , Ȯ
- üġ ϴ ȯ ε ӻ ϰ , ؿܿ ӻ Ǿǰ 켱
- ͳġȯڸ '' : ȯ ӻ ġ û ó
- ӻ ȭ, ä پȭ, » Ȯ
- ľó û ˻, OECD о Ż ٷΰ
- Ǿ R&D Ż ߱ 뱹 ̵ ٷΰ
- VN10072 / ǥؿ /
ȯڿ VN10072 ൿ Ư ϱ 뷮 1 ӻ / 1 / γ ֽȸ / 2019-08-13
- ָ(MEDI-563) / ߵ ⼺ ȯ(COPD) ΰ ְ
COPD ȭ ȣ걸 ִ ȯڸ Benralizumab 100 mg ȿ ϱ
ٱ, , , Ⱓ , ౺, , 3 ӻ(RESOLUTE) / 3 / ѱƽƮī() / 2019-08-12
- MK-3475 / ༺ /Ǵ Ұ 㵵 ȯڸ 1 μ
Pembrolizumab + Gemcitabine/Cisplatin + Gemcitabine/Cisplatin ϴ 3,
, ߴ ӻ / 3 /
ѱ() / 2019-08-12
- 縿(MEDI9929, AMG157) / ߵ ⼺ ȯ(COPD) ȯڸ
Tezepelumab ȿ ϱ , , , ౺, ٱ, 2a
ӻ(COURSE) / 2a / ѱƽƮī() / 2019-08-12
- PDR001 / μ Ǵ ٸ ӻ ġ Ƽ Ƿ
spartalizumab ӻ迡 ߴ ڿ ༺ Ư ľ , ٱ, ȯ
ӻȹ / 1b /
ѱƼ() / 2019-08-12
- ASP-1929 / ּ ſ ݵ ּ ġḦ
ġῡ ߰ų , ұ ΰ Ǽ ȯ ġῡ ASP-1929 鿪 ǻ ǥ ġ
3, , ߱, ӻ, / 3 /
ѱť() / 2019-08-09
- BMI2006100(ŬνƮA) / ߵ Ǵ ָ̰ ʿ ȯڸ
BMI2006100 彺 ָ̰ ȿ 1/2 ӻ / 1/2 /ֽȸ ѱ / 2019-08-09
- CG200745 / ǰ CG-745 IV ֻ CG-750
ĸ ൿ , ϱ , , , ܰ , ӻ / 1 /
ũŻͽ() / 2019-08-08
- AD-203 / Ǵ ȯڸ AD-203 ȿ
ϱ , ߴ, Ȱ, , ٱ, 3 ӻ / 3 /
ֵĸ ֽȸ / 2019-07-31
ؿ ӻ (clnicaltrials.gov 2019.08.06~2019.08.12)
<̱> - NCT04034485 / Phase 3 Study to Evaluate the Efficacy and
Safety of LIB003 With Evolocumab in HoFHHomozygous Familial Hypercholesterolemia / Drug: LIB003|Drug: evolocumab / LIB Therapeutics LLC /Phase 3
8
High-precision plasma -amyloid 42/40 predicts current and future brain amyloidosis ( ġ ȯ )2019. 8. Ǵ * the peptide amyloid beta plays a role in Alzheimer's disease. image reference: Washington Univ., phys.org žళ߿ ߰ شȭ (Unlocking the power of translational medicine)2019. 8. óžళ * image reference: Nature Review Drug Discovery 2019 ICH ̵ ǰǾǰ KoBIA(ѱ̿Ǿǰȸ), KRPIA ְ Safety α & ! <Ÿ >- ۷ιȼ ۼ PTȭ(Ƿ Թ), ѱǺη°߿, 8 28()-29() [Click]
- Biosafety Verification System of Biologics GMP facility Workshop 2019, зϾ ưȣ, 8 21() 14[Click]
- CPhI Korea 2019, ڿ,8 21()~23() [Click]
- KoBIA ȸ ȫ ȳ [Click]
- [-DIA] ICH Workshop, ư, 9 6() [Click]
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