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[問題] OECD GLP v.s. FDA GLP?
Nov 4th 2013, 10:00, by joycefong

作者joycefong (boborax)

看板Bioindustry

標題[問題] OECD GLP v.s. FDA GLP?

時間Mon Nov 4 10:00:03 2013

請教板上各位先進，一個有關申請國外藥證時，所需毒理試驗GLP類別問題 我知道美國 FDA 會接受依據OECD ＧＬＰ規範所進行之藥物安全性試驗。 但我想知道ＥＭＡ（歐盟）或日本、澳洲等國家 會不會接受ＦＤＡＧＬＰ規範所進行之藥物安全性試驗？ 或是在美國ＬＡＢ，依據OECD ＧＬＰ規範所進行之藥物安全性試驗？ 　　 多謝指教 -- ※ 發信站: 批踢踢實業坊(ptt.cc) ◆ From: 114.44.129.236

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