Advanced statistics in regulatory critical clinical initiatives / edited by Wei Zhang, Fangrong Yan, Feng Chen and Shein-Chung Chow
Complex innovative design / Beibei Guo and Ying Yuan -- Validation strategy for biomarker guided precision/personalized medicine / Hou, Y., Li, M.J., and Li, K. -- Model-informed drug development / Haochen Liu, Fangrong Yan -- Real-world data and real-world evidence / Xin Sun -- AI/ML in medical research and drug development / Amir Nikooienejad and Haoda Fu -- Challenges in cancer clinical trials / Xia, Fan; Lin, Xiao; Guo, Xiang -- Statistical methods for assessment of biosimilars / Yafei Zhang, Vivian Gu, Xiuyu Julie Cong, and Shein-Chung Chow -- Statistical methods for assessment of complex generic drugs -- Rare diseases drug development / Shein-Chung Chow, Shutian Zhang, Wei Zhang..
"The subject of the proposed book primarily focuses on recent critical clinical initiatives as the result of the 21st Century Cure Act passed by the United States Congress in December 2016. The proposed book will include innovative design and analysis of each critical clinical initiatives in biopharmaceutical research and development from both regulatory and scientific (statistical) perspectives. The proposed book is designed for pharmaceutical researchers and/or scientists at master or doctoral level of biostatistics or related areas"--.
| Medienart: |
Buch |
|---|
| Erscheinungsjahr: |
2022 |
|---|---|
| Erschienen: |
Boca Raton London New York: CRC Press, Taylor & Francis Group ; 2022 |
| Ausgabe: |
First edition |
| Reihe: |
|---|
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Zhang, Wei [HerausgeberIn] |
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| ISBN: |
|---|
| Themen: |
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| Anmerkungen: |
Includes bibliographical references and index |
|---|
| Umfang: |
x, 307 Seiten |
|---|
| doi: |
10.1201/9781003107323 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
1783419008 |
|---|
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| 520 | |a "The subject of the proposed book primarily focuses on recent critical clinical initiatives as the result of the 21st Century Cure Act passed by the United States Congress in December 2016. The proposed book will include innovative design and analysis of each critical clinical initiatives in biopharmaceutical research and development from both regulatory and scientific (statistical) perspectives. The proposed book is designed for pharmaceutical researchers and/or scientists at master or doctoral level of biostatistics or related areas"-- | ||
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