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
:
Library | Material Type | Item Barcode | Shelf Number | [[missing key: search.ChildField.HOLDING]] | Status |
---|
Online Library | E-Book | 291131-1001 | ONLINE | | Elektronik Kütüphane |