バイオ医薬品のCTD-Q作成 : 妥当性の根拠とまとめ方

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Summary, etc.：: ―日本及び海外を見据えたバイオ医薬品開発に際しどのような観点でCTD（品質パート）を作成すべきかーCTD M2、M3の品質パートに関する内容に焦点を当て、バイオ医薬品の開発段階毎における当局要求事項・実務面留意事項と申請資料へ提示する際の考え方を紹介！バイオ医薬品における構造解析・⁮特性解析、製造工...

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Material Type: 図書
ISBN: 978-4-86428-168-3
Title: バイオ医薬品のCTD-Q作成 : 妥当性の根拠とまとめ方
Title Transcription: バイオイヤクヒンノ CTD-Q サクセイ : ダトウセイノコンキョトマトメカタ
Publication, Distribution, etc.: 東京 : サイエンス&テクノロジー
Publication Date: 2018.1
Publication Date (W3CDTF): 2018
Extent: 171p
Size: 26cm
Place of Publication (Country Code): JP
Text Language Code: jpn
Subject Heading: 新薬承認シンヤクショウニン ( 01199484 )Authorities
バイオ医薬品バイオイヤクヒン ( 01196760 )Authorities
NDC 10th ed.: 499.091 : Pharmaceutics
NDLC: A581
Target Audience: 一般
Note (Bibliography): 文献あり
Price: 45000円
Holding library: 国立国会図書館
Call No.: A581-L30
Data Provider (Database): 国立国会図書館 : 国立国会図書館蔵書
https://ndlsearch.ndl.go.jp
Bibliographic ID (NDL): 028784613
http://id.ndl.go.jp/bib/028784613
National Bibliography No. (JPNO): 23014255
Cataloging Rule: Nippon Cataloguing Rules 1987 Revised Edition
Bibliographic Record Category (NDL): 111