和訳資料 業界への指...

和訳資料 業界への指針案 : 開発後期及び市販後の臨床研究において必要とされる安全性データ収集の程度の決定

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和訳資料 業界への指針案 : 開発後期及び市販後の臨床研究において必要とされる安全性データ収集の程度の決定

Call No. (NDL)
Z19-834
Bibliographic ID of National Diet Library
025964320
Material type
記事
Author
小宮山 靖 翻訳ほか
Publisher
東京 : 日本公定書協会
Publication date
2014
Material Format
Paper
Journal name
医薬品医療機器レギュラトリーサイエンス = Pharmaceutical and medical device regulatory science 45(12):2014
Publication Page
p.974-979
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Paper

Material Type
記事
Author/Editor
小宮山 靖 翻訳
酒井 弘憲 翻訳
兼山 達也 翻訳他
Alternative Title
Guidance for Industry : Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations [DRAFT GUIDANCE]
Periodical title
医薬品医療機器レギュラトリーサイエンス = Pharmaceutical and medical device regulatory science
No. or year of volume/issue
45(12):2014
Volume
45
Issue
12
Pages
974-979