バイオ医薬品のCTD-Q作成 : 妥当性の根拠とまとめ方
バイオ医薬品のCTD-Q作成 : 妥当性の根拠とまとめ方
- Call No. (NDL)
- A581-L30
- Bibliographic ID of National Diet Library
- 028784613
Detailed bibliographic record
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...
Search by Bookstore
Table of Contents
第1章 バイオ医薬品における特異事項と同等性/同質性評価
はじめに
1. 全体の流れ
1.1 重要品質特性の特定
1.2 製造工程の開発
Holdings of Libraries in Japan
This page shows libraries in Japan other than the National Diet Library that hold the material.
Please contact your local library for information on how to use materials or whether it is possible to request materials from the holding libraries.
Kanto
東京都立中央図書館
Paper- Call No.：
- 499.0-5587-2018
- Book Registration Number：
- 7110957487
other
CiNii Research
Search ServicePaperYou can check the holdings of institutions and databases with which CiNii Research is linked at the site of CiNii Research.
Search by Bookstore
Publication bibliographic database 
Find a bookstore where you can purchase books from
Books is a database of the publishing industry with information provided by publishers. You can search for currently available paperbacks and eBooks.
Find by another way
Bibliographic Record
You can check the details of this material, its authority (keywords that refer to materials on the same subject, author's name, etc.), etc.
- Material Type
- 図書
- ISBN
- 978-4-86428-168-3
- 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.
- Publication Date
- 2018.1
- Publication Date (W3CDTF)
- 2018
- Extent
- 171p
- Size
- 26cm
- Place of Publication (Country Code)
- JP