Design and analysis of bioavailability and bioequivalence studies

Bibliographic Details
Main Authors: Chow, Shein-Chung , 1955- (Author), Liu, Jen-pei , 1952- (Author)
Format: Book
Language:English
Published: New York : Marcel Dekker , c2000
Edition:2nd ed. revised and expanded
Subjects:

MARC

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020 |a 0824775724 (pbk.) 
050 0 0 |a RM301.6   |b .C46 2009 
060 1 0 |a QV 38   |b C552d 2009 
090 0 0 |a QV 38   |b C552d 2009 
100 1 |a Chow, Shein-Chung ,   |d 1955- ,   |e author 
245 1 0 |a Design and analysis of bioavailability and bioequivalence studies   |c Shein-Chung Chow, Jen-pei Liu 
250 |a 2nd ed. revised and expanded 
260 |a New York :   |b Marcel Dekker ,   |c c2000 
300 |a xii, 584 p. ;   |c 26 cm. 
504 |a Includes bibliographical references (p. 521-535) and index 
505 0 |a 1. Introduction -- 2. Designs of bioavailability studies -- 3. Statistical inferences for effects from a standard 2x2 crossover design -- 4. Statistical methods for average bioavailability -- 5. Power and sample size determination -- 6. Transformation and analysis of individual subjects rations -- 7. The assessment of inter and intrasubject variabilities -- 8. Assumptions and outliers detection -- 9. Optimal crossover designs for two formulations -- 10. Assessment of bioequivalence for more than two formulations -- 11. Assessment of bioequivalence for drugs with negligible plasma levels -- 12. Some related problems in bioavailability studies -- 13. Meta-Analysis for bioequivalence review -- 14. Population and individual bioequivalence -- 15. Statistical procedures for assessment of population and individual bioequivalence -- 16. Review of FDA guidances 
650 0 |a Bioavailability   |x Research   |x Statistical methods 
650 0 |a Drugs   |x Therapeutic equivalency   |x Research   |x Statistical methods 
650 1 2 |a Biological Availability 
650 2 2 |a Statistics as Topic   |x methods 
650 2 2 |a Therapeutic Equivalency 
700 1 |a Liu, Jen-pei ,   |d 1952- ,   |e author 
999 |a 1000135523   |b Book   |c Open Shelf (1 Day)   |e Medical Campus