Design and analysis of bioavailability and bioequivalence studies [electronic resource] / authors, Shein-Chun Chow, Jen-pei Liu.

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Bibliographic Details
Online Access: Full Text (via Taylor & Francis)
Main Author: Chow, Shein-Chung, 1955-
Other Authors: Liu, Jen-pei, 1952-
Format: Electronic eBook
Language:English
Published: Boca Raton : Chapman & Hall/CRC, 2009.
Edition:3rd ed.
Series:Chapman & Hall/CRC biostatistics series ; 27.
Subjects:

MARC

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245 1 0 |a Design and analysis of bioavailability and bioequivalence studies  |h [electronic resource] /  |c authors, Shein-Chun Chow, Jen-pei Liu. 
250 |a 3rd ed. 
260 |a Boca Raton :  |b Chapman & Hall/CRC,  |c 2009. 
300 |a 1 online resource (pages ). 
336 |a text  |b txt  |2 rdacontent 
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490 1 |a Chapman & Hall/CRC biostatistics series ;  |v 27 
504 |a Includes bibliographical references and index. 
505 0 |a Design of bioavailability studies -- Statistical inferences for effects from a standard 22 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intrasubject 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 |a Bioavailability  |x Research  |x Statistical methods. 
650 0 |a Drugs  |x Therapeutic equivalency  |x Research  |x Statistical methods. 
650 0 |a Bioavailability.  |0 http://id.loc.gov/authorities/subjects/sh88003406 
650 0 |a Drugs  |x Therapeutic equivalency.  |0 http://id.loc.gov/authorities/subjects/sh85039756 
650 7 |a Bioavailability.  |2 fast 
650 7 |a Drugs  |x Therapeutic equivalency.  |2 fast 
700 1 |a Liu, Jen-pei,  |d 1952-  |0 http://id.loc.gov/authorities/names/n92033064  |1 https://id.oclc.org/worldcat/entity/E39PBJgd643vC6Y4JQjTfwTPwC  |1 http://isni.org/isni/0000000109366146 
776 0 8 |i Print version:  |a Chow, Shein-Chung, 1955-  |t Design and analysis of bioavailability and bioequivalence studies.  |b 3rd ed.  |d Boca Raton : Chapman & Hall/CRC, 2009  |w (DLC) 2008025461 
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