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Innovative statistics in regulatory ...

Chow, Shein-Chung, (1955-)

Innovative statistics in regulatory science /

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Innovative statistics in regulatory science /Shein-Chung Chow.
作者:	Chow, Shein-Chung,
出版者:	Boca Raton :CRC Press,c2020.
面頁冊數:	xxi, 530 p. :ill. ;24 cm.
標題:	DrugsTesting.
ISBN:	9780367224769 (hbk.) :

Innovative statistics in regulatory science /
Chow, Shein-Chung,1955-

Innovative statistics in regulatory science /Shein-Chung Chow. - Boca Raton :CRC Press,c2020. - xxi, 530 p. :ill. ;24 cm. - Chapman & Hall/CRC biostatistics series. - Chapman & Hall/CRC biostatistics series..

Includes bibliographical references and index.

Totality-of-the-evidence -- Hypotheses testing versus confidence interval -- Endpoint selection -- Non-inferiority margin -- Missing data -- Multiplicity -- Sample size -- Reproducible research -- Extrapolation -- Consistency evaluation -- Drug products with multiple components -- Adaptive trial design -- Selection criteria in adaptive dose finding -- Generic drugs and biosimilars -- Precision and personalized medicine -- Big data analytics -- Rare disease drug development.

"The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"--

ISBN: 9780367224769 (hbk.) :NT$3594

LCCN: 2019026376Subjects--Topical Terms:

183737
Drugs
--Testing.

LC Class. No.: RM301.27 / .C476 2020

Dewey Class. No.: 615.1072/4

Innovative statistics in regulatory science /
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020 $a 0367224763 (hbk.)
020 $z 9780429275067 (pdf)
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050 0 0 $a RM301.27 $b .C476 2020
082 0 0 $a 615.1072/4 $2 23
100 1 $a Chow, Shein-Chung, $d 1955- $3 188933
245 1 0 $a Innovative statistics in regulatory science / $c Shein-Chung Chow.
260 $a Boca Raton : $b CRC Press, $c c2020.
300 $a xxi, 530 p. : $b ill. ; $c 24 cm.
490 1 $a Chapman & Hall/CRC biostatistics series
504 $a Includes bibliographical references and index.
505 0 $a Totality-of-the-evidence -- Hypotheses testing versus confidence interval -- Endpoint selection -- Non-inferiority margin -- Missing data -- Multiplicity -- Sample size -- Reproducible research -- Extrapolation -- Consistency evaluation -- Drug products with multiple components -- Adaptive trial design -- Selection criteria in adaptive dose finding -- Generic drugs and biosimilars -- Precision and personalized medicine -- Big data analytics -- Rare disease drug development.
520 $a "The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science"-- $c Provided by publisher.
650 0 $a Drugs $x Testing. $3 183737
650 0 $a Clinical trials $x Statistical methods. $3 181899
650 0 $a Pharmacy $x Research. $3 724112
650 0 $a Research $x Statistical methods. $3 185277
830 0 $a Chapman & Hall/CRC biostatistics series. $3 508409