000			01827nam a2200241Ia 4500
008			250806s9999||||xx |||||||||||||| ||und||
020			_a9781584886686 (hardcover : alk. paper)
060			_aQV 38 _b.C46 2009
100			_aChow, Shein-Chung,
245		0	_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.
490			_aChapman & Hall/CRC biostatistics series
500			_aA Chapman & Hall book.
504			_aIncludes bibliographical references (p. 647-667) and index.
505			_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			_aBiological Availability
650			_aStatistics as Topic
650			_aTherapeutic Equivalency
700			_aLiu, Jen-pei,
942			_bDIMC _cBK
999			_c25714 _d25714