Design and Analysis of Bioavailability and Bioequivalence Studies Book

	Series Introduction
	Preface
	Preface to the First Edition
1	Introduction	1
2	Designs of Bioavailability Studies	31
3	Statistical Inferences for Effects from a Standard 2 x 2 Crossover Design	57
4	Statistical Methods for Average Bioavailability	79
5	Power and Sample Size Determination	125
6	Transformation and Analysis of Individual Subject Ratios	161
7	The Assessment of Inter- and Intrasubject Variabilities	187
8	Assumptions and Outliers Detection	221
9	Optimal Crossover Designs for Two Formulations	257
10	Assessment of Bioequivalence for More Than Two Formulations	303
11	Assessment of Bioequivalence for Drugs with Negligible Plasma Levels	333
12	Some Related Problems in Bioavailability Studies	361
13	Meta-Analysis for Bioequivalence Review	379
14	Population and Individual Bioequivalence	401
15	Statistical Procedures for Assessment of Population and Individual Bioequivalence	443
16	Review of FDA Guidances	489
	References	521
	App. A: Statistical Tables	537
App. B	SAS Programs	557
	Index	577