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Design and analysis of bioavailabili...

Chow, Shein-Chung, (1955-)

Design and analysis of bioavailability and bioequivalence studies /

Record Type:	Language materials, printed : Monograph/item
Title/Author:	Design and analysis of bioavailability and bioequivalence studies /Shein-Chun Chow, Jen-pei Liu.
Author:	Chow, Shein-Chung,
other author:	Liu, Jen-pei,
Published:	Boca Raton :CRC Press,c2009.
Description:	xxii, 733 p. :ill. ;25 cm.
Notes:	"A Chapman & Hall book."
Series:	Chapman & Hall/CRC biostatistics series ;
Subject:	BioavailabilityResearch
Online resource:	http://www.loc.gov/catdir/toc/ecip0821/2008025461.html
ISBN:	1584886684 (hardback : alk. paper) :

Design and analysis of bioavailability and bioequivalence studies /
Chow, Shein-Chung,1955-

Design and analysis of bioavailability and bioequivalence studies /Shein-Chun Chow, Jen-pei Liu. - 3rd ed. - Boca Raton :CRC Press,c2009. - xxii, 733 p. :ill. ;25 cm. - 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: 1584886684 (hardback : alk. paper) :NT$2968

LCCN: 2008025461

Nat. Bib. Agency Control No.: 101475977DNLMSubjects--Topical Terms:

377593
Bioavailability
--Research

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

Dewey Class. No.: 615/.7

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

Design and analysis of bioavailability and bioequivalence studies /
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035 $a 2008025461
040 $a DNLM/DLC $c DLC $d NLM $d BTCTA $d BAKER $d YDXCP $d OCLCG $d C#P $d OCLNG $d BWX $d CDX $d DLC
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100 1 $a Chow, Shein-Chung, $d 1955- $3 188933
245 1 0 $a Design and analysis of bioavailability and bioequivalence studies / $c Shein-Chun Chow, Jen-pei Liu.
250 $a 3rd ed.
260 $a Boca Raton : $c c2009. $b CRC Press,
300 $a xxii, 733 p. : $b ill. ; $c 25 cm.
440 0 $a Chapman & Hall/CRC biostatistics series ; $v 27
500 $a "A Chapman & Hall book."
504 $a Includes bibliographical references (p. 647-667) and index.
505 0 $a 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.
650 0 $a Bioavailability $x Research $x Statistical methods. $3 377593
650 0 $a Drugs $x Therapeutic equivalency $x Research $x Statistical methods. $3 377594
650 1 2 $a Biological Availability. $3 301753
650 2 2 $a Statistics as Topic $x methods. $3 265580
650 2 2 $a Therapeutic Equivalency. $3 265613
700 1 $a Liu, Jen-pei, $d 1952- $3 224744
856 4 1 $3 Table of contents only $u http://www.loc.gov/catdir/toc/ecip0821/2008025461.html