Design and analysis of bioavailability and bioequivalence studies
by
 
Chow, Shein-Chung, 1955-

Title
Design and analysis of bioavailability and bioequivalence studies

Author
Chow, Shein-Chung, 1955-

ISBN
9781420011678

Edition
3rd ed.

Publication Information
Boca Raton : Chapman & Hall/CRC, 2009.

Physical Description
760 p.

Series
Chapman & Hall/CRC biostatistics series ; 27

Series Title
Chapman & Hall/CRC biostatistics series ; 27

Contents
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.

Subject Term
Bioavailability -- Research -- Statistical methods.
 
Drugs -- Therapeutic equivalency -- Research -- Statistical methods.

Added Author
Liu, Jen-pei, 1952-

Electronic Access
Distributed by publisher. Purchase or institutional license may be required for access.


LibraryMaterial TypeItem BarcodeShelf Number[[missing key: search.ChildField.HOLDING]]Status
Online LibraryE-Book291131-1001ONLINEElektronik Kütüphane