Chow, Shein-Chung,  1955- <br/><br/>
Design and analysis of bioavailability and bioequivalence studies / 
Shein-Chung Chow, Jen-pei Liu 
 - 3rd ed 
 - Boca Raton :  CRC Press,  c2009 
 - xxii, 733 p. :  ill. ;  25 cm 
 - Chapman & Hall/CRC biostatistics series ;  27 .
 - Chapman & Hall/CRC biostatistics series ;  27 .
<br/><br/>Includes bibliographical references (p. 647-667) and index 
<br/><br/>Design 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 
<br/><br/><label>ISBN: </label>9781584886686 (hardback : alk. paper) 1584886684 (hardback : alk. paper) 
<br/><br/><label>LCCN: </label>2008025461 
<br/><br/><label>Nat. Bib. Agency Control No.: </label>101475977  DNLM 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Bioavailability--Research--Statistical methods<br/>Drugs--Therapeutic equivalency--Research--Statistical methods<br/>Biological Availability<br/>Statistics as Topic--methods<br/>Therapeutic Equivalency
<br/><br/><label>LC Class. No.: </label>RM301.6  / .C46 2009 RM301.6  / .C46 2009 
<br/><br/><label>Dewey Class. No.: </label>615.7