Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition BABE-Solution bundle Version / Edition 3

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Overview

Containing four new chapters, along with several new and updated sections, this third edition reviews the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. It presents the current status of regulations on bioavailability and bioequivalence, including guidelines/guidances issued by the FDA, EMEA, and WHO. This edition addresses frequently asked questions and explores sample size determination, meta-analysis, and pharmacokinetics. It also offers a basic version of PharmaSoftware Solutions, Inc.’s BABE Solution 2008, with bioequivalence assessment for in vivo bioequivalence studies.

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Product Details

Table of Contents

Preface

Preliminaries

Introduction

History of Bioavailability Studies

Formulation and Routes of Administration

Pharmacokinetic Parameters

Clinically Important Differences

Assessment of Bioequivalence

Decision Rules and Regulatory Aspects

Statistical Considerations

Aims and Structure of the Book

Design of Bioavailability Studies

Introduction

Study Objective

Basic Design Considerations

Parallel Design

The Crossover Design

Balanced Incomplete Block Design

Selection of Design

Statistical Inference for Effects from a Standard 2 × 2 Crossover Design

Introduction

Carryover Effects

Direct Drug Effect

Period Effect

Analysis of Variance

An Example

Average Bioequivalence

Statistical Methods for Average Bioequivalence

Introduction

Confidence Interval Approach

Methods of Interval Hypothesis Testing

Bayesian Methods

Nonparametric Methods

Discussion and Other Alternatives

Power and Sample Size Determination

Introduction

Hypotheses and Type I and Type II Errors

Power and Relative Efficiency

Sample Size Determination

Transformation and Analysis of Individual Subject Ratios

Introduction

Multiplicative (or Log-Transformed) Model

Bioequivalence Measures

Maximum Likelihood Estimator

Minimum Variance Unbiased Estimator

Mean of Individual Subject Ratios

Ratio of Formulation Means

Comparison of MLE, MVUE, MIR, and RM

An Example

Discussion

Assessment of Inter- and Intrasubject Variabilities

Introduction

Variability and Decision Making

Point and Interval Estimates

Test for Equality of Variabilities

Equivalence in Variability of Bioavailability

CV Assessment

Discussion

Assumptions of Outlier Detection for Average Bioequivalence

Introduction

Tests for Assumptions

Definition of Outlying Observations

Detection of Outlying Subjects

Detection of Outlying Observations

Discussion

Optimal Crossover Designs for Two Formulations for Average Bioequivalence

Introduction

Balaam’s Design

Two-Sequence Dual Design

Optimal Four-Period Designs

Transformation and Individual Subject Ratios

Sample Size for Higher-Order Crossover Designs

Discussion

Assessment of Average Bioequivalence for More Than Two Formulations

Introduction

Assessment of Average Bioavailability with More Than Two Formulations

Analyses for Williams Designs

Analysis for Balanced Incomplete Block Design

Discussion

Population and Individual Bioequivalence

Population and Individual Bioequivalence

Introduction

Limitation of Average Bioequivalence

Merits of Individual Bioequivalence and Desirable Bioequivalence Criteria

Measures of Discrepancy

Probability-Based Criteria

Moment-Based Criteria

Relations among Criteria

Bioequivalence Limits

Designs for Population and Individual Bioequivalence

Discussion

Statistical Procedures for Assessment of Population and Individual Bioequivalence

Introduction

Estimation Procedures

Procedures for Moment-Based Criteria

Procedures for Probability-Based Criteria

Generalized p-Values for Evaluation of Population Bioequivalence

Discussion

In Vitro and Alternative Evaluation of Bioequivalence

Assessment of Bioequivalence for Drugs with Negligible Plasma Levels

Introduction

Design and Clinical Endpoints

Statistical Considerations

Weighted Least Squares Methods

Log-Linear Models

Generalized Estimating Equations

Analysis of Time to Onset of a Therapeutic Response

Discussion

In Vitro Bioequivalence Testing

Introduction

Study Design and Data Collection

Bioequivalence Limit

Statistical Methods

An Example

Sample Size Determination

Discussion

In Vitro Dissolution Profiles Comparison

Introduction

Criterion for Assessment of Similarity between Dissolution Profiles

Inference for Similarity Factors

Approaches Based on Multivariate Confidence Regions

An Example

Discussion

Other Bioequivalence Studies

Meta-Analysis for Bioequivalence Review

Introduction

Meta-Analysis for Average Bioequivalence

Alternative Method for Meta-Analysis

Efficiency of Meta-Analysis

Discussion

Population Pharmacokinetics

Introduction

Regulatory Requirements

Population PK Modeling

Design of Population PK

An Example

Discussion

Other Pharmacokinetic Studies

Introduction

Drug Interaction Studies

Dose Proportionality Study

Steady-State Analysis

Evaluation of Food Effects

Discussion

Review of Regulatory Guidances on Bioequivalence

Introduction

Guidances on Statistical Procedures

Guidances on General Considerations for Bioequivalence

Guidances on Bioequivalence for Special Drug Products

Critical Path Opportunities for Generic Drugs

Discussion

Frequently Asked Questions and Future Challenges

Introduction

Assessment of Bioequivalence Using Genomic Information

Bridging Bioequivalence Studies

Bioequivalence for Biological Products

Frequently Asked Questions in Bioequivalence

Discussion

References

Appendix A: Statistical Tables

Appendix B: SAS Programs

Index

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