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[Į]ICH ̵ ӻ ȯ ȭ
ϸ 2018-08-21 06:29:30
[Į]ICH ̵ ӻ ȯ ȭ
ϸ 2018-08-21 06:29:30
(PPCڸ)



ӻڵ鿡 ־ ӻ ʼ ħ ICH GCP (ICH E6) 20⸸ 2 .

ICH GCP ӻ ȯ濡  ĥ, ӻ ͸  ȭ , ȭ  ɵ óϰ غ ֱ ӻ ڵ ֵ ɻ翴. ICH GCP ó ӻ ȯ濡 ȭ ־. ȭ ݿϱ GCP ̵ ʿ̾ ̴.

2016 GCP ġ ʰ ϰ پ ӻ پ ڷ ƿ츣 ħ ֵ GCP (GCP Renovation) ǰ ִ. ICH E6 E8 ߽ GCP ۾ ̷ , Concept Paper ǥ ܰ ӻ ȯ ʾ ū ñ⸦ ް ִ.

ICH E6(R2) ٽ ϳ GMP о߸ ߽ ۵ƴ Quality-by-Design(QbD) Quality Risk Management GCP Եƴٴ ̰ ̴ ICH Q9 ӻ迡 ϰ ؼȴ. , ӻ󿡼 QbD ޾Ƶ鿩 ӻ Ƿ åӰ ֿ 赵 ǰ (Risk-based quality management) 赵 ͸ (Risk-based monitoring; RBM) ϰ ̴.

ӻ ȿ 踦 Quality Risk Management 켱 ϰ ִµ, ̴ ʹ ϸ ȯ 忡 ӻ ʰ, ŷڼ ִ ϴ Ұ ִٴ ޽ ְ ִ. ſ ǰ ϸ, ܼ ǰ(QA) ǰ(QC) Ȱ , ǰ ӻ ο ȹ, ͸ ݿ 赵 м Ͽ ȹϰ 䱸ϰ ִ.

GCP Ӹ ƴ϶, GxP Ȱ Ͽ Quality Management System(QMS) ϴ ƴ. ȭ ٱ QMS Ӱ ǥؾ(SOP) ̳, ۷ι QMS ۵ǰ ִ ȸ ϴ.

ICH-GCP ٽ ϳ RBM ֱ ӻ ۷ 翡 ߵ , RBM ӻ ڵ ص ٰ ִ. ο ǹ ʾҰ, Ϻ ӻ󿡼 ù ǰ ִ Ȳ̴. RBM ؼ ӻ Ƿڴ 켱 赵 ϰ ̸ ü ͸ ؾ Ѵ.

, 赵 ȹ ͸ 湮 ͸(on-site monitoring) ߾ ͸(centralized monitoring) ν ñ ǰ ȣ Ҹ ϰų ȭϴ ͸ Ȱ ִ. ̷ RBM 赵 ǰ ȹ Ŀ , ʴ´ٸ ͸ ṵ̈(holistic), ߽(data-driven) RBM . ٿ, մ 赵 ͸ RBM Ͽ 湮 ͸ ܼ ҽŰ ´ 籹 ̴.

RBM ſ ߿ ߾ ͸ ӻ ǽñκ ǻȭ ý ͸ ñ ϰ ϰ ϴ Ȱ̸, ̷ ߾ ͸ Ȱ 湮 ͸ Ȱ ǰ ȭž Ѵٴ ؾ Ѵ. ߾ ͸ ͸ RBM ֿ μ, ̸ ϱ м 䱸ȴ.

, ߾ ͸ ߽ ͸ Ȱ ٽ̶ , ǰų ġ ڷ, , Ǵ ؼ ÿ ĺ ִ. ֱ Ⱓ ߾ ͸ Ǿ , ̷ м RBM ÷ ϴ ȸ絵 ܳ ƴ.

׷, EDC ýۿ ͸ ϴ ߾ ͸ Ȱ Ư , κ ٱ ۷ι CRO ߾ ͸ ϴ ѱ ƴ ؿܿ ġϰ ִ. ߾ ͸ ǰ , ۷ι RBM . ӻ ڵ Ư ߾ ͸ η 缺 ߿ϴ.

ó ICH GCP ǹ ϰ ݿ Ȳ ICH GCP ̳ ѹ յΰ ִ. ICH E8 ӻ Ϲ μ, E8 ο ǰ ȭ ̾ ִ ο ٷ ʴ. , E8 ϴ (RCT) ѵ , ó ȰǴ پ Ư ݿ ϰ ִ. ̷ ذϱ E8(R1) پ ӻ ϸ, ٽǰ (Critical-to-Quality factor) Ȯ ְ, پ ڷ ϴ ̴.

ƿ﷯ E6 ߰ ִ. ICH E6 ڰǰ Ǵ ȯ ÿ ڷ real world data Ȱ ǿ ӻ󿬱(pragmatic clinical trial; PCT) ࿡ ħ η ż ȹ ǥߴ. PCT ȯ ܱ ּ ȯ濡 ̻ (intervention) ȿ ϴӻ󿬱̴. , PCT ȯڸ ϴ RCT ޸ Ƿȯ濡 ġ ȿ ϴ ·μ Ϲȭ , ȯ ߽ ̶ ִ. Ư Ȱ ߿ ֱ PCT ߿伺 Ŀ ̴.

޺ϴ ӻ ȯ濡 ɵ óϱ ؼ ̵ο Ȯ ظ QbD, ǰ RBM ý ǥؾ(SOP) ʿϰڰ, ٰ ̵ ؼ ϰ óϰ нϴ ڼ ʿϰڴ.

ٵ ڵ н ʼ̸, ӻ ϴ ϼ Ϳ å ƴ϶, ӻ ο ϴ 濵 ȯ ʿϴ. ӻ ȹ, ϰ ϴ ޹ħž ̴. ο ȭ ӻ迡 ü ٹ , ȹ Ȯ ҵ ̴. Robin S. Sharma ۱͸ ø ģ. Change is hard at first, messy in the middle, and gorgeous at the end.
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ֽż ݴ
ٺ Ϲݾ ǸŰ (2024 04)
౹ 31
ǰ ְ
ѽŻ÷(10) 3,500 2,500 1,000 3,009
޾(100) 24,000 23,000 1,000 23,200
Ʒγΰ(100) 30,000 28,000 2,000 28,500
īɾ(10g) 7,000 6,000 1,000 6,559
Ľõ򿬰(5g) 5,000 4,500 500 5,138
Ź(4) 5,000 4,000 1,000 4,438
ڶ(20) 6,000 6,000 0 6,000
(10) 6,000 4,500 1,500 5,071
Ժ(10) 4,000 3,500 500 3,712
ڱ׸(20) 5,000 4,500 500 4,717
ť(10) 3,000 2,500 500 2,990
Ȱť(1) 1,200 900 300 1,182
Ǯɾ(3.3ml) 26,000 23,000 3,000 24,250
޵𿬰(10g) 7,000 5,900 1,100 6,289
öŸ(34) 13,000 11,000 2,000 11,866
뽺ī(20g) 22,000 18,000 4,000 20,184
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 8,500 1,500 9,205
ͺ(10) 3,500 3,000 500 3,196
ݿ(1ڽ) 3,000 3,000 0 3,000
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,524
߽Ÿ(120) 70,000 50,000 20,000 60,385
Źĸ(10ĸ) 3,000 2,000 1,000 2,989
Ÿ̾(120) 60,000 50,000 10,000 51,538
տ(60ĸ) 29,000 25,000 4,000 27,600
Ÿ̷ER(6) 3,000 2,500 500 2,750
ٿ(30g) 12,000 9,000 3,000 11,444
(120) 25,000 22,000 3,000 24,991
Ʒ(6) 4,000 3,000 1,000 3,262
ǽõĸ(270ĸ) 110,000 110,000 0 110,000
B(120) 70,000 70,000 0 70,000
׳(10) 3,000 2,500 500 2,778
6̺(10) 3,000 3,000 0 3,000
(60) 230,000 220,000 10,000 223,333
Ⱦ 12,000 10,000 2,000 10,143
̰źĸ(60ĸ) 35,000 30,000 5,000 33,231
Ųť(20) 5,500 4,500 1,000 4,903
λ絹÷(100) 35,000 32,000 3,000 33,297
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