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Biosimilar Drug Product Development.
・ISBN 978-1-4987-1879-0 hard GB£ 210.00
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| 著者・編者 | Endrenyi, Laszlo / Declerck, . Paul / Chow, Shein-Chung (eds.), |
|---|---|
| シリーズ | (Drugs and the Pharmaceutical Sciences) |
| 出版社 | (CRC Press Inc, US) |
| 出版年月 | 2017 |
| ページ数 | 496 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A01-92061＞ |
解説
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.