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
Summary
"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."
