Design and Analysis of Bioavailability and Bioequivalence Studies, Second Edition

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.