Design and Analysis of Bioavailability and Bioequivalence Studies - Rilegato

Chow, Shein-Chung; Liu, Jen-pei

Rilegato

ISBN 10: 0824775724 ISBN 13: 9780824775728

Casa editrice: CRC Press, 1999

Riassunto

"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."

Su questo libro

Contenuti

Designs of bioavailability studies; statistical inferences for effects from a standard 2x2 crossover design; statistical methods for average bioavailability; power and sample size determination; transformation and analysis of individual subject ratios; the assessment of inter- and intrasubject variabilities; assumptions and outliers detection; optimal crossover designs for two formulations; assessment of bioequivalence for more than two formulations; assessment of bioequivalence for drugs with negligible plasma levels; some related problems in bioavailability studies; metanalysis for bioequivalence - review; population and individual bioequivalence; review of FDA guidances. Appendices: statistical tables; SAS programs.

Product Description

Book by Chow SheinChung Liu Jenpei

Dettagli dell'edizione

• Editore: CRC Press
• Data di pubblicazione: 1999
• Lingua: Inglese
• ISBN 10: 0824775724
• ISBN 13: 9780824775728
• Rilegatura: Copertina rigida
• Numero edizione: 2
• Numero di pagine: 600
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile