Chow, Shein-Chung, <br/><br/>
Design and analysis of bioavailability and bioequivalence studies / 
Shein-Chun Chow, Jen-pei Liu. 
 - 3rd ed. 
 - Boca Raton :  CRC Press,  c2009. 
 - xxii, 733 p. :  ill. 
 - Chapman & Hall/CRC biostatistics series  .
<br/><br/> A Chapman & Hall book. 
<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 (hardcover : alk. paper) 
<br/><br/><label>Subjects--Topical Terms: </label><br/>Biological Availability<br/>Statistics as Topic<br/>Therapeutic Equivalency
<br/><br/><label>National Library of Medicine Call No.: </label>QV 38  / .C46 2009