Bio Iyakuhin No Hinshitsu Kanri Senryaku (Yuko Sei Anzen Sei Kakuho No Tame No)
Kawanishi Toru / Kanshu Kawasaki Nana Cho
| Points You Earn | 1% (50p) |
|---|---|
| Release Date | July 2015 |
| Availability | Sold Out |
Product Details
| Catalog No. | NEOBK-1842800 |
|---|---|
| JAN/ISBN | 9784840747257 |
| Product Type | BOOK |
| Pages | 215 |
|---|
Books are basically written in Japanese except for bilingual books or ones indicated as not written only in Japanese.
Description in Japanese
有効性・安全性確保のためのバイオ医薬品の品質管理戦略 クオリティ・バイ・デザインを取り入れた製造・品質管理 / 川西徹/監修 川崎ナナ/監著
Related Offer & Feature
Tracklisting
| 1 |
第1章 バイオ医薬品のクオリティ・バイ・デザインの概略
|
| 2 |
第2章 品質特性解析(構造解析
|
| 3 |
不純物の評価
|
| 4 |
安定性)
|
| 5 |
第3章 品質管理戦略の構築と臨床・非臨床試験(薬物動態と品質特性
|
| 6 |
薬理作用と品質特性
|
| 7 |
免疫原性)
|
| 8 |
第4章 品質管理(製造要件(製造用細胞基材
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| 9 |
製造工程管理)
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| 10 |
ウイルス安全性
|
| 11 |
規格及び試験方法
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| 12 |
バイオ医薬品の標準品・標準物質)
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| 13 |
第5章 品質管理戦略の構築と主なリスクアセスメント技法(バイオ医薬品のクオリティ・バイ・デザイン)
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| 14 |
第6章 バイオ後続品(バイオ後続品の開発と品質評価)
|
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