Design and analysis of bioavailability and bioequivalence studies
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Main Authors: | |
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Group Author: | |
Published: |
CRC Press,
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Publisher Address: | Boca Raton |
Publication Dates: | c2009. |
Literature type: | Book |
Language: | English |
Edition: | 3rd ed. |
Series: |
Chapman & Hall/CRC biostatistics series ; 27 |
Subjects: | |
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. |