regulatory starting material

Japanese translation: (FDAの)規制に適合する出発物質

01:48 Jan 14, 2018
English to Japanese translations [PRO]
Medical - Medical: Pharmaceuticals / CMC
English term or phrase: regulatory starting material
Starting materialだけと出発物質、ですが、Regulatoryはこの場合どのように訳すのがよいのでしょうか?

The regulatory starting material is used for ----

という感じで書かれています。

おねがいします!
ellenaK
United States
Local time: 00:54
Japanese translation:(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。
Selected response from:

Tsunehiko Tarumoto
United States
Local time: 03:54
Grading comment
Thank you!!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +2(FDAの)規制に適合する出発物質
Tsunehiko Tarumoto
2規制上の出発物質
cinefil


  

Answers


7 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5
規制上の出発物質


Explanation:
http://www.nihs.go.jp/drug/section3/SakuraS2Mock.pdf

cinefil
Japan
Local time: 16:54
Works in field
Native speaker of: Native in JapaneseJapanese
PRO pts in category: 68
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2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
(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-...
Tsunehiko Tarumoto
United States
Local time: 03:54
Specializes in field
Native speaker of: Native in JapaneseJapanese, Native in EnglishEnglish
PRO pts in category: 4
Grading comment
Thank you!!

Peer comments on this answer (and responses from the answerer)
agree  Chrisso (X)
1 day 20 hrs

agree  DPurohit (X)
3 days 21 hrs
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