Design and Analysis of Bioavailability and Bioequivalence Studies"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." |
Contents
Introduction | 1 |
Designs of Bioavailability Studies | 31 |
Statistical Inferences for Effects from a Standard 2x2 Crossover Design | 57 |
Statistical Methods for Average Bioavailability | 79 |
Power and Sample Size Determination | 125 |
Transformation and Analysis of Individual Subject Ratios | 161 |
The Assessment of Inter and Intrasubject Variabilities | 187 |
Assumptions and Outliers Detection | 221 |
Assessment of Bioequivalence for Drugs with Negligible Plasma Levels | 333 |
Some Related Problems in Bioavailability Studies | 361 |
MetaAnalysis for Bioequivalence Review | 379 |
Population and Individual Bioequivalence | 401 |
Statistical Procedures for Assessment of Population and Individual Bioequivalence | 443 |
Review of FDA Guidances | 489 |
| 521 | |
Statistical Tables | 537 |
Optimal Crossover Designs for Two Formulations | 257 |
Assessment of Bioequivalence for More Than Two Formulations | 303 |
SAS Programs | 557 |
Other editions - View all
Design and Analysis of Bioavailability and Bioequivalence Studies, Second ... Shein-Chung Chow,Jen-pei Liu No preview available - 1999 |
Common terms and phrases
aggregate criteria analysis of variance assessment of bioequivalence AUC data average bioavailability average bioequivalence bioavailability studies bioequivalence limits bioequivalence studies bootstrap Cmax coefficient conclude confidence interval confidence limit covariance matrix data set degrees of freedom difference direct drug effect dose drug product equivalence limits evaluation example expected values FDA guidance Fieller's formulation effect Hauck higher-order crossover design hypotheses Eq individual bioequivalence individual subject ratios interval hypotheses intrasubject residuals intrasubject variability linear Liu and Chow log-transformed mean squared error model Eq MVUE n₁ n₂ ni+n2 nonparametric normality assumption null hypothesis number of subjects obtained one-sided tests procedure p-value parameters period effect Period Sequence pharmacokinetic responses population bioequivalence proc sort quantile random reference formulation reject sample Schuirmann's two one-sided sequence-by-period means statistical inference subject-by-formulation interaction test and reference test formulation therapeutic window type I error unbiased estimator Williams design Yijk