| 000 | 02453cam a22004214a 4500 | ||
|---|---|---|---|
| 999 |
_c2565 _d2565 |
||
| 001 | 166358489 | ||
| 003 | OCoLC | ||
| 005 | 20170225143930.0 | ||
| 008 | 080606s2009 flua b 001 0 eng | ||
| 010 | _a2008025461 | ||
| 016 | 7 |
_a101475977 _2DNLM |
|
| 020 | _a9781584886686 (hardback : alk. paper) | ||
| 020 | _a1584886684 (hardback : alk. paper) | ||
| 035 | _a.b65775855 | ||
| 040 |
_aDNLM/DLC _cDLC _dNLM _dBTCTA _dBAKER _dYDXCP _dOCLCG _dC#P _dOCLNG _dBWX _dUtOrBLW |
||
| 042 | _apcc | ||
| 049 | _aOSU& | ||
| 050 | 0 | 0 |
_aRM301.6 _b.C46 2009 |
| 050 | 0 | 0 |
_aRM301.6 _b.C46 2009 |
| 082 | _a615.7 | ||
| 100 | 1 |
_aChow, Shein-Chung, _d1955- |
|
| 245 | 1 | 0 |
_aDesign and analysis of bioavailability and bioequivalence studies / _cShein-Chung Chow, Jen-pei Liu |
| 250 | _a3rd ed | ||
| 260 |
_aBoca Raton : _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 |
|
| 650 | 1 | 2 | _aBiological Availability |
| 650 | 2 | 2 |
_aStatistics as Topic _xmethods |
| 650 | 2 | 2 | _aTherapeutic Equivalency |
| 700 | 1 |
_aLiu, Jen-pei, _d1952- |
|
| 830 | 0 |
_aChapman & Hall/CRC biostatistics series ; _v27 |
|
| 942 |
_2ddc _cBK |
||