01:48 Jan 14, 2018 |
English to Japanese translations [PRO] Medical - Medical: Pharmaceuticals / CMC | |||||||
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| Selected response from: Tsunehiko Tarumoto United States Local time: 03:54 | ||||||
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4 +2 | (FDAの)規制に適合する出発物質 |
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2 | 規制上の出発物質 |
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規制上の出発物質 Explanation: http://www.nihs.go.jp/drug/section3/SakuraS2Mock.pdf |
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(FDAの)規制に適合する出発物質 Explanation: https://www.gmp-compliance.org/gmp-news/api-starting-materia... 出発物質あるいは原薬はFDAの定める ICH-Q11の要件を満たすものでなければならない。例えば中間生成物などを出発物質として申請することはできない。 Reference: http://https://www.gmp-compliance.org/gmp-news/api-starting-... |
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