Reset Filters
Can I borrow online: Online

Cover is for reference only

Design and analysis of bioavailability and bioequivalence studies

Saved in:
Bibliographic Details
Main Authors: Chow Shein-Chung, 1955-
Group Author: Liu Jen-pei, 1952-
Published: CRC Press,
Publisher Address: Boca Raton
Publication Dates: c2009.
Literature type: Book
Language: English
Edition: 3rd ed.
Series: Chapman & Hall/CRC biostatistics series ; 27
Subjects:
Drugs > Therapeutic equivalency > Research > Statistical methods.
Biological Availability.
Statistics as Topic > methods.
Therapeutic Equivalency
Bioavailability > Research > Statistical methods.
Carrier Form: xxii, 733 p.: ill. ; 25 cm.
ISBN: 9781584886686 (hardback : alk. paper)
1584886684 (hardback : alk. paper)
Index Number: R969
CLC: R969.1-32
Call Number: R969.1-32/C552/3rd.ed.
Contents: "A Chapman & Hall book."
Includes bibliographical references (p. 647-667) and index.
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.

Related Book Recommendations