MARC Record from Library of Congress

LEADER: 02163nam a22003498a 4500
001 2008025461
003 DLC
005 20080617113944.0
008 080606s2009 flu b 001 0 eng
010 $a 2008025461
020 $a9781584886686 (hardback : alk. paper)
035 $a(DNLM)101475977
040 $aDNLM/DLC$cDLC
042 $apcc
050 00 $aRM301.6$b.C46 2009
060 10 $aQV 38$bC552d 2009
082 00 $a615/.7$222
100 1 $aChow, Shein-Chung,$d1955-
245 10 $aDesign and analysis of bioavailability and bioequivalence studies /$cauthors, Shein-Chun Chow, Jen-pei Liu.
250 $a3rd ed.
260 $aBoca Raton :$bChapman & Hall/CRC,$c2009.
263 $a0809
300 $ap. ;$ccm.
440 0 $aChapman & Hall/CRC biostatistics series ;$v27
504 $aIncludes bibliographical references and index.
505 0 $aDesign of bioavailability studies -- Statistical inferences for effects from a standard 22 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intrasubject 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-