24.03.28 () 21:02

Dailypharm

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"FDA 㰡 ڷ ȭ ´"
뺴ö 2020-05-28 06:20:42
"FDA 㰡 ڷ ȭ ´"
뺴ö 2020-05-28 06:20:42
ä Ƽر׷ ȸ, ӻ ڹ α׷

ž ڷ ŵ쳪 CRO


  ä ȸ
[ϸ=뺴ö ] "̹ ߵ 'SEND' ۷ι ǥ ӻ ڹ ǥ, ̿ FDA 㰡 ڷ ȭ ˴ϴ."

Ƽؾ ׷ ä ȸ ȸ CRO Ƽؾ˿ ü ߿ SEND(Standard for Exchange of Non-clinical Dataӻ ڹ ȯ α׷) ߴ.

SEND ̱ FDA ӻȹ(IND), ž㰡(NDA) û ӻ͸ ڹ ϴ Ī Ѵ.

FDA 2017 ϴ ӻ ͸ SEND ° ȯ ǹȭ ۷ι ǥ ýۿ ϴ ѱ α׷ Ȳ̾.

Ƽؾ˿ 2 α׷ӡ η 10 10 ƽþ ʷ SEND ߿ ߴ. CRO ʷ 򰡹ް ִ. ̱ CRO ý ࿡ ʿ ū ̶ ִ.

"SEND LIMS( ڵ α׷) ڵ ǵ , SEND ͸ ٰŷ Define file, nSDRG, Final Report ν μ ϼ˴ϴ. LIMS SEND Ͱ ǵ ٽ Դϴ."

׵ ӻ LIMS ؿܿ ¾ Դ. ̷ ӿ  ü, ߰ SEND Ʈ LIMS ̴ SEND ִ GLP Ұ ȭ ߴ.

SEND ȭ ǹ̴ õ ų Ʈ,  ν ž FDA ִ.

ƿ﷯ ľó ȭ ۾ õ ְ SEND Ʈ ȭμ £ پ ְ ƴ.

"̹ SEND ߷ Ƽؾ˿ ϴ One-Stop Total CRO 񽺸 Ѵܰ ׷̵ ״ٰ մϴ. ܼ ӻ Ѿ ž ڷ ŵ쳪 -̿ ּ ϰڽϴ."

Ƽؾ ׷ 衤 Ƽؾ, ̿ 񽺱 Ƽؾ˿(ӻ󡤺мӻ㰡), Ƽػ޵(ž 123 PMS, PV) Safe Soft(Ʈ 򰡡), óijŻ, ߱, Ϻ, Ʈ 3 ؿ 9 ȸ ִ.

ä ȸ Ϲϴ.

-Ƽؾ˿ ü鿡 ߿ ұϰ, ª Ⱓ α ϰ ֽϴ. ȭ ִٸ Ұ ֽʽÿ.

=2017 ȸ ӵ ľó ǽñ (2018.03), ӻGLP (2019.09) ޾, ̸鼭 One-Stop Total CRO 񽺸 žళ ϴ ý ϰ ֽϴ.

2019⿡ 2 ľó ǥ Ȳ αǿ ߽ϴ. ӻ, м, ӻ RA 㰡 о 踹 ְ (MOPS) ǰߵ Ϸ 鲲 ߾ ֽ ̶ մϴ..

-Ƽؾ˿ ƽþ ʷ FDA ӻ ǥ(SEND) IT α׷ ϰ ִ ˰ ֽϴ. ̿ Ź帳ϴ.

=SEND(Standard for Exchange of Non-clinical Data) ̿ FDA ӻȹ(IND), ž㰡(NDA) û ӻ͸ ڹ ϴ Ī մϴ. FDA ϴ ӻ͸ 2017 SEND ° ȯ ǹȭ߽ϴ. ӻ žĺ ȿ ϴ Դϴ.

-SEND ϰԵ Դϱ?

=SEND LIMS( ڵ α׷) ڵ ǵ , SEND data ٰŷ Define file, nSDRG, Final Report μ μ ϼ Ǵ Դϴ. LIMS SEND data ǵ ٽ ε ӻ LIMS ؿܿ setupϰ ִ Դϴ.

̷ ӿ  ü, ߰ SEND Update LIMS ̴ SEND ִ GLP Ұϰ ˴ϴ. ׷ ICT ȸμ ̷ ICTо߿ Ȳ ո Ȳ Խϴ. ׷ ̷ ӿ ־ ߰ â ̷ ִٴ ߿ ϰ ƽϴ.

-SEND ð, η  ϼ̽ϱ?

=Software ߻ ȸ SafeSoft ְ η° Ƽؾ˿ TF 10 2 ԰, 1 Ϸ Ǵ FDA SEND߿ ְ ؿ δް ۾ ־ϴ.

-Ƽؾ˿ ϴ SEND ⿡ Ź帳ϴ.

= 񽺷 뺰 ֽϴ.

ù° GLP û SEND data û ϸ Ϸ ÿ SEND data Set ϴ Դϴ.

° Ÿ ǽ ߴ GLP ޾SEND Data ϴ 񽺵 غ Ǿ ֽϴ. ȯ ۾ ϱ 鿡 ˴ϴ.

° FDA û ؼ SEND Data Set, Define file, nSDRG, Final Report ʿ FDA ְ ؿ Consultant Collaboration FDA full ִ 񽺸 ϼ߽ϴ.

-ȸ ϴ SEND α׷ ǹ̴ Դϱ?

=õ ų Update,  μ Bio ventures, ž FDA Ϻκ ִ ⿩ϰ ֽϴ.

ľó ȭ ۾ õ ְ ν SEND Կ ũ ⿩ ֽϴ.

׸ SEND Software ȭμ £ پ ְ Ǿϴ.

-Ƽؾ˿3 (ӻ, м ӻ)  ȹ  Ǵ Ź帳ϴ.

= , ȿ, 漺 ϸ鼭 Ǿǰ ִ 񽺰 ϵ ƽþ ؿ ⿡ Դϴ.

- ο Ź帳ϴ.

= Ƽؾ˿ о߿ ް ֵ Բ ȹԴϴ.

׸ ׻ ο ν CROо Ϸ ǵ ּ ϰڽϴ.

 å ֽ ̿ ںе鲲 ȸ 縦 帮 ͽϴ.
뺴ö (sasiman@dailypharm.com) ٸ
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ǰ ְ
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ѽŻ÷(10) 3,500 2,500 1,000 3,144
޾(100) 24,000 22,000 2,000 22,800
Ʒγΰ(100) 30,000 27,000 3,000 28,586
īɾ(10g) 8,000 5,500 2,500 6,773
Ľõ򿬰(5g) 5,500 4,000 1,500 5,104
Ź(4) 5,000 3,500 1,500 4,350
λ絹÷(100) 37,000 30,000 7,000 33,889
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Ժ(10) 4,000 3,300 700 3,699
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Ȱť(1) 1,200 1,000 200 1,199
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޵𿬰(10g) 7,000 6,000 1,000 6,463
öŸ(34) 13,000 11,000 2,000 12,009
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Ⱦ 12,000 10,000 2,000 10,967
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