ѹα ù° Ǿ ͳݽŹ 1999 6 ϸ â 16ֳ ¾Ҵ. ϸ ڵ ɰ Ȥ ӿ Ѱ ư Ѻ 츮 Ǿǰ 2000 8 Ǿо ũ ߴ. žళ ɷ , ɷ ȭ, GMP , ǰ鿡 ߴ. ̰ Ǿǰ Ƿü ٷμ 'ô ⸳' ϱ پ Ѵ. 帮 ҹ Ʈ ȭϴµ 弭 ̴. к ۷ι ΰ ɷ° ڰ ִٰ ϰ ѹѹ ۷ι ؾ Ѵ.
߰ ۷ι ̴
2015 츮 迡 ð ̼ ܾ ۷ι ϴ ̴. ۷ι 忡 ü 40%, 50% س ȸ þ Ǿ Ѵ. ̷ Ǿǰ ֱ Ű ȣ ؾ ̴. ۷ι ̶ Ƿ ڸ ø 縦 ü øµ Ϸθ ؾѴ. ۽Ʈ Ŭ ž, Ʈ Ŭ ž, ž, ̿ž, ̿ , ̿ ùз, ۽Ʈ , ÷Ʈ о߿ Ȱ¦ ȸ ã ʿ䰡 ִ. ۷ι 忡 ų '' ãµ Ҷ.
۷ι ϴµ ־ ΰ ۿ . δ 2020 Ʈ ȭǵ ɼ ϰ å ÿ 弭 Ѵ. Բ ̴ ʴ. 1987 Ư Ե 籹 ճ ſ , Ǿ. ž 24 , ƴٴ FDA 㰡 ܳ ε ӵ ð ִ ̴. Ͻ ߽̱, ̷ Ȳ ߱ݾ߱ ø R&D Ÿ Ʒ ִ. ؼ ʿ ' Կ츱 Ҹ ϴ' ̴.
ֵ Ǿǰ Ѿ,
Ǿǰ ߴٰ ϳ , ٽø ()̶ 鿡 ʴ. ӻ 㰡 鿡 ǰ ӵǰ ִµ ó Ǿǰ ǻó, ο ϼ ౹ ܰ迡 Ÿ ִ. Ư ǰ ü谡 Ǿǰ ϴܰ迡 ˼ϴ ǰ Ȯϴ ý̶, δ QbD Ͽ Ȯϴ Ϸ ΰ غϰ ִ. Ӹ ƴ϶ ̷ ִ Ϸùȣ ǹȭѴ.
̰ Ǿǰ ϰ µ Ǵ 'Ǹ Ͽ ִ' ̴ պ ߸ Ǿǰ ߸ ۿ . ȥǴ , ǰ, Ǿǰ ݰ óڰ ȭ , ü ū ġ ͵̴. Ϻ ȸ ̼ ִ ã κ ȸ ߰ ܸϰ ִ Ȳ̴. δ ٷ ؼ ȵȴ. Ǿǰ ǥ ο ౹ Ȱ ִ ľϰ ȸ , ع ؾ ̴. Ǿǰ GMP, QbD ذ ̴. Ǿǰ Ѵܰ ö Ѵ.
ϸ (dailypharm@dailypharm.com)
ٸ
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