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Biosimilar Clinical Development: Scientific Considerations and New Methodologies.
・ISBN 978-0-367-73652-1 paper GB£ 54.99
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| 著者・編者 | Barker, Kerry B. / Menon, Sandeep M. / D'Agostino, Sr., Ralph B. / Xu, Siyan / Jin, PhD, Bo (eds.), |
|---|---|
| シリーズ | (Chapman & Hall/CRC Biostatistics Series) |
| 出版社 | (Chapman & Hall/CRC, UK) |
| 出版年月 | 2020 |
| ページ数 | 248 pp. |
| 言語 | ENG |
| ニュース番号 | ＜A00-42650＞ |
解説
Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.