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008 100705t2009 flud f 001 0 eng d
020 _a9781584886686
039 9 _a201208081156
_bFida
_c201208081028
_dida
_c201107131831
_dVLOAD
_c201012031205
_dFida
_y201007051641
_zshikin
040 _aUMP
090 _aRM301.6 .C46 2009
100 1 _aChow, Shein-Chung
245 1 0 _aDesign and analysis of bioavailability and bioequivalence studies /
_cShein-Chun Chow, Jen-pei Liu
250 _a3rd ed.
260 _aBoca Raton, Florida :
_bCRC Press,
_cc2009
300 _axxii, 733 p. :
_bill. ;
_c25 cm.
490 1 _aChapman & Hall/CRC biostatistics series ;
_v27
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
700 1 _aLiu, Jen-pei
830 0 _aChapman & Hall/CRC biostatistics series ;
_v27
856 4 1 _3Table of contents only
_uhttp://www.loc.gov/catdir/toc/ecip0821/2008025461.html
999 _aVIRTUA40
_c29921
_d29927
999 _aVTLSSORT0080*0200*0400*0900*1000*2450*2500*2600*3000*4900*5040*5050*6500*6501*7000*8300*8560*9992