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Drug Development for Rare Diseases.
・ISBN 978-0-367-51834-9 hard GB£ 145.99
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電子版あり 大学・学術機関向け電子ブック（eBook）ISBN 978-1-003-08095-4
| 著者・編者 | Yang, Bo / Song, Yang / Zhou, Yijie (eds.), |
|---|---|
| シリーズ | Chapman & Hall/CRC Biostatistics Series |
| 出版社 | (Chapman & Hall/CRC, UK) |
| 出版年月 | 2023 |
| ページ数 | 222 pp. |
| 言語 | ENG |
| ニュース番号 | ＜M25-15061＞ |
解説
A disease is defined as rare if the prevalence is fewer than 200,000 in the United States. It is estimated that there are more than 7,000 rare diseases, which collectively affect 30 million Americans or 10% of the US population. This diverse and complex disease area poses challenges for patients, caregivers, regulators, drug developers, and other stakeholders. This book is proposed
to give an overview of the common issues facing rare disease drug developers, summarize challenges specific to clinical development in small populations, discuss drug development strategies in the evolving regulatory environment, explain generation and utilization of different data and evidence
inside and beyond clinical trials, and use recent examples to demonstrate these challenges and the development strategies that respond to the challenges.
Key Features:
* Rare disease.
* Drug development.
* Innovative clinical trial design.
* Regulatory approval.
* Real-world evidence.