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010 a| 2021048220;

020 a| 9780367561789q| (hardback);

020 a| 9780367609955q| (paperback);

020 z| 9781003107323q| (ebook);

035 a| (WaSeSS)ssj0002543947;

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050 00 a| RM301.27b| .A38 2022;

082 00 a| 615.1072/42| 23/eng/20211220;

245 00 a| Advanced statistics in regulatory critical clinical initiativesh| [electronic resource] /c| edited by Wei Zhang, Fangrong Yan, Feng Chen and Shein-Chung Chow.;

250 a| First edition.;

260 a| Boca Raton :b| CRC Press,c| 2022.;

263 a| 2203;

300 a| pages cm.;

490 0 a| Statistics;

504 a| Includes bibliographical references and index.;

505 0 a| 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.;

506 a| Available only to authorized users.;

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"--c| Provided by publisher.;

538 a| Mode of access: World Wide Web;

610 10 a| United States.t| 21st Century Cures Act.=| ^A1368766;

650 0 a| Drugsx| Testingx| Statistical methods.=| ^A4660;

650 0 a| Clinical trialsx| Statistical methods.=| ^A990883;

650 0 a| Biometry.=| ^A1379;

650 0 a| Drugsx| Standardsz| United States.=| ^A1001117;

650 0 a| Clinical trialsx| Law and legislationz| United States.=| ^A856874;

655 0 a| Electronic books.=| ^A491897;

700 1 a| Zhang, Weic| (Biometrician)?| UNAUTHORIZED;

700 1 a| Yan, Fangrong.?| UNAUTHORIZED;

700 1 a| Chen, Fengc| (Professor of biostatistics)?| UNAUTHORIZED;

700 1 a| Chow, Shein-Chung,d| 1955-=| ^A296792;

856 40 z| Full text available from Taylor & Francis eBooksu| https://go.openathens.net/redirector/ecu.edu?url=https%3A%2F%2Fwww.taylorfrancis.com%2Fbooks%2F9781003107323;

949 a| CLICK ON WEB ADDRESSw| ASISh| JOYNER188;

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999 a| CLICK ON WEB ADDRESSw| ASISc| 1i| 6655287-3001l| MNETm| JMUSICr| Ys| Yt| MNESSBKu| 12/18/2025x| EBOOKz| JERESOURCE;

Advanced statistics in regulatory critical clinical initiatives / edited by Wei Zhang, Fangrong Yan, Feng Chen and Shein-Chung Chow.

Format	Electronic
Edition	First edition.
Publication Info	Boca Raton : CRC Press, 2022.
Description	pages cm.
Supplemental Content	Full text available from Taylor & Francis eBooks
Subjects	United States. 21st Century Cures Act. Drugs--Testing. --Statistical methods. Clinical trials--Statistical methods. Biometry. Drugs--Standards. --United States. Clinical trials--Law and legislation. --United States.

Other author/creator	Zhang, Wei (Biometrician)
Other author/creator	Yan, Fangrong.
Other author/creator	Chen, Feng (Professor of biostatistics)
Other author/creator	Chow, Shein-Chung, 1955-
Series	Statistics
Contents	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.
Abstract	"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"-- Provided by publisher.
Bibliography note	Includes bibliographical references and index.
Access restriction	Available only to authorized users.
Technical details	Mode of access: World Wide Web
Genre/form	Electronic books.
LCCN	2021048220
ISBN	9780367561789 (hardback)
ISBN	9780367609955 (paperback)
ISBN	(ebook)

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Advanced statistics in regulatory critical clinical initiatives / edited by Wei Zhang, Fangrong Yan, Feng Chen and Shein-Chung Chow.

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