MARC Record from Library of Congress

LEADER: 02501cam a22004094a 4500
001 2008025461
003 DLC
005 20090901064011.0
008 080606s2009 flua b 001 0 eng
010 $a 2008025461
016 7 $a101475977$2DNLM
020 $a9781584886686 (hardback : alk. paper)
020 $a1584886684 (hardback : alk. paper)
035 $a(OCoLC)166358489
042 $apcc
050 00 $aRM301.6$b.C46 2009
060 00 $a2008 M-918
060 10 $aQV 38$bC552d 2009
082 00 $a615/.7$222
035 $a(OCoLC)ocn166358489
040 $aDNLM/DLC$cDLC$dNLM$dBTCTA$dBAKER$dYDXCP$dOCLCG$dC#P$dOCLNG$dBWX$dCDX$dDLC
100 1 $aChow, Shein-Chung,$d1955-
245 10 $aDesign and analysis of bioavailability and bioequivalence studies /$cShein-Chun Chow, Jen-pei Liu.
250 $a3rd ed.
260 $aBoca Raton :$bCRC Press,$cc2009.
300 $axxii, 733 p. :$bill. ;$c25 cm.
440 0 $aChapman & Hall/CRC biostatistics series ;$v27
500 $a"A Chapman & Hall book."
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.
650 0 $aDrugs$xTherapeutic equivalency$xResearch$xStatistical methods.
650 12 $aBiological Availability.
650 22 $aStatistics as Topic$xmethods.
650 22 $aTherapeutic Equivalency.
700 1 $aLiu, Jen-pei,$d1952-
856 41 $3Table of contents only$uhttp://www.loc.gov/catdir/toc/ecip0821/2008025461.html