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Design and analysis of bioavailability and bioequivalence studies

正題名/作者 : Design and analysis of bioavailability and bioequivalence studies/ Shein-Chung Chow, Jen-pei Liu.

作者 : Chow, Shein-Chung,

其他作者 : Liu, Jen-pei,

出版者 : Boca Raton :CRC Press,c2009.

面頁冊數 : 1 online resource (xxii, 733 p.) :ill.

附註 : "A Chapman & Hall book."

叢書名 : Chapman & Hall/CRC biostatistics series ;

標題 : Bioavailability - Research -

電子資源 : 線上閱讀(EBSCO)

ISBN : 9781584886686 (hbk.)

ISBN : 1584886684 (hbk.)

ISBN : 9781420011678 (electronic bk.)

ISBN : 1420011677 (electronic bk.)

LEADER 02428cmm 2200325 a 450

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006 m d

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020 $a9781584886686 (hbk.)

020 $a1584886684 (hbk.)

020 $a9781420011678 (electronic bk.)

020 $a1420011677 (electronic bk.)

035 $a00192606

050 4$aRM301.6$b.C46 2009eb

060 4$aQV 38$bC552d 2009

082 04$a615/.7$222

090 $aE-BOOK/615.7//2009///UM039664

100 1 $aChow, Shein-Chung,$d1955-$3192680

245 10$aDesign and analysis of bioavailability and bioequivalence studies$h[electronic resource] /$cShein-Chung Chow, Jen-pei Liu.

250 $a3rd ed.

260 $aBoca Raton :$bCRC Press,$cc2009.

300 $a1 online resource (xxii, 733 p.) :$bill.

440 0$aChapman & Hall/CRC biostatistics series ;$v27

500 $a"A Chapman & Hall book."

500 $aDescription based on print version record.

504 $aIncludes bibliographical references (p. 647-667) and index.

505 0 $aDesign of bioavailability studies -- Statistical inferences for effects from a standard 2x2 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intra-subject variabilities -- Assumptions of outlier detection for average bioequivalence -- Optimal crossover designs for two formulations for average bioequivalence -- Assessment of bioequivalence for more than two formulations -- Population and individual bioequivalence -- Statistical procedures for assessment of population and individual bioequivalence -- Assessment of bioequivalence for drugs with negligible plasma levels -- In vitro bioequivalence testing -- In vitro dissolution profiles comparison -- Meta-analysis for bioequivalence review -- Population pharmacokinetics -- Other pharmacokinetic studies -- Review of regulatory guidances on bioequivalence -- Frequently asked questions and future challenges.

650 0$aBioavailability$xResearch$xStatistical methods.$3300978

650 0$aDrugs$xTherapeutic equivalency$xResearch$xStatistical methods.$3300979

650 12$aBiological Availability.$3300980

650 22$aStatistics as Topic$xmethods.$3300681

650 22$aTherapeutic Equivalency.$3300981

700 1 $aLiu, Jen-pei,$d1952-$3192681

776 08$iPrint version:$aChow, Shein-Chung, 1955-$tDesign and analysis of bioavailability and bioequivalence studies.$b3rd ed.$dBoca Raton : CRC Press, c2009$z9781584886686$z1584886684$w(DLC) 2008025461$w(OCoLC)166358489

856 40$3NetLibrary$uhttps://erm.library.ntpu.edu.tw/login?url=http://www.netlibrary.com/urlapi.asp?action=summary&v=1&bookid=248268$z線上閱讀(EBSCO)

Chow, Shein-Chung,1955-

Design and analysis of bioavailability and bioequivalence studies[electronic resource] /Shein-Chung Chow, Jen-pei Liu. - 3rd ed. - Boca Raton :CRC Press,c2009. - 1 online resource (xxii, 733 p.) :ill. - Chapman & Hall/CRC biostatistics series ;27.

"A Chapman & Hall book."

Includes bibliographical references (p. 647-667) and index.

Design of bioavailability studies -- Statistical inferences for effects from a standard 2x2 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intra-subject variabilities -- Assumptions of outlier detection for average bioequivalence -- Optimal crossover designs for two formulations for average bioequivalence -- Assessment of bioequivalence for more than two formulations -- Population and individual bioequivalence -- Statistical procedures for assessment of population and individual bioequivalence -- Assessment of bioequivalence for drugs with negligible plasma levels -- In vitro bioequivalence testing -- In vitro dissolution profiles comparison -- Meta-analysis for bioequivalence review -- Population pharmacokinetics -- Other pharmacokinetic studies -- Review of regulatory guidances on bioequivalence -- Frequently asked questions and future challenges.

ISBN: 9781584886686 (hbk.) Subjects--Topical Terms:

300978
Bioavailability
--Research

LC Class. No.: RM301.6 / .C46 2009eb

Dewey Class. No.: 615/.7

National Library of Medicine Call No.: QV 38 / C552d 2009
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