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

Hardcover (Print)
Used and New from Other Sellers
Used and New from Other Sellers
from $628.90
Usually ships in 1-2 business days
Other sellers (Hardcover)
  • All (1) from $628.90   
  • New (1) from $628.90   
Sort by
Page 1 of 1
Showing All
Note: Marketplace items are not eligible for any coupons and promotions
Seller since 2011

Feedback rating:



New — never opened or used in original packaging.

Like New — packaging may have been opened. A "Like New" item is suitable to give as a gift.

Very Good — may have minor signs of wear on packaging but item works perfectly and has no damage.

Good — item is in good condition but packaging may have signs of shelf wear/aging or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Acceptable — item is in working order but may show signs of wear such as scratches or torn packaging. All specific defects should be noted in the Comments section associated with each item.

Used — An item that has been opened and may show signs of wear. All specific defects should be noted in the Comments section associated with each item.

Refurbished — A used item that has been renewed or updated and verified to be in proper working condition. Not necessarily completed by the original manufacturer.

Brand new and unread! Join our growing list of satisfied customers!

Ships from: Phoenix, MD

Usually ships in 1-2 business days

  • Standard, 48 States
  • Standard (AK, HI)
Page 1 of 1
Showing All
Sort by

More About This Textbook


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.

Read More Show Less

Product Details

  • ISBN-13: 9781439813584
  • Publisher: Taylor & Francis
  • Publication date: 3/23/2009
  • Series: Chapman & Hall/CRC Biostatistics Series
  • Edition number: 3
  • Pages: 760
  • Product dimensions: 0.61 (w) x 0.92 (h) x 1.50 (d)

Table of Contents




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


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


Carryover Effects

Direct Drug Effect

Period Effect

Analysis of Variance

An Example

Average Bioequivalence

Statistical Methods for Average Bioequivalence


Confidence Interval Approach

Methods of Interval Hypothesis Testing

Bayesian Methods

Nonparametric Methods

Discussion and Other Alternatives

Power and Sample Size Determination


Hypotheses and Type I and Type II Errors

Power and Relative Efficiency

Sample Size Determination

Transformation and Analysis of Individual Subject Ratios


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


Assessment of Inter- and Intrasubject Variabilities


Variability and Decision Making

Point and Interval Estimates

Test for Equality of Variabilities

Equivalence in Variability of Bioavailability

CV Assessment


Assumptions of Outlier Detection for Average Bioequivalence


Tests for Assumptions

Definition of Outlying Observations

Detection of Outlying Subjects

Detection of Outlying Observations


Optimal Crossover Designs for Two Formulations for Average Bioequivalence


Balaam’s Design

Two-Sequence Dual Design

Optimal Four-Period Designs

Transformation and Individual Subject Ratios

Sample Size for Higher-Order Crossover Designs


Assessment of Average Bioequivalence for More Than Two Formulations


Assessment of Average Bioavailability with More Than Two Formulations

Analyses for Williams Designs

Analysis for Balanced Incomplete Block Design


Population and Individual Bioequivalence

Population and Individual Bioequivalence


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


Statistical Procedures for Assessment of Population and Individual Bioequivalence


Estimation Procedures

Procedures for Moment-Based Criteria

Procedures for Probability-Based Criteria

Generalized p-Values for Evaluation of Population Bioequivalence


In Vitro and Alternative Evaluation of Bioequivalence

Assessment of Bioequivalence for Drugs with Negligible Plasma Levels


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


In Vitro Bioequivalence Testing


Study Design and Data Collection

Bioequivalence Limit

Statistical Methods

An Example

Sample Size Determination


In Vitro Dissolution Profiles Comparison


Criterion for Assessment of Similarity between Dissolution Profiles

Inference for Similarity Factors

Approaches Based on Multivariate Confidence Regions

An Example


Other Bioequivalence Studies

Meta-Analysis for Bioequivalence Review


Meta-Analysis for Average Bioequivalence

Alternative Method for Meta-Analysis

Efficiency of Meta-Analysis


Population Pharmacokinetics


Regulatory Requirements

Population PK Modeling

Design of Population PK

An Example


Other Pharmacokinetic Studies


Drug Interaction Studies

Dose Proportionality Study

Steady-State Analysis

Evaluation of Food Effects


Review of Regulatory Guidances on Bioequivalence


Guidances on Statistical Procedures

Guidances on General Considerations for Bioequivalence

Guidances on Bioequivalence for Special Drug Products

Critical Path Opportunities for Generic Drugs


Frequently Asked Questions and Future Challenges


Assessment of Bioequivalence Using Genomic Information

Bridging Bioequivalence Studies

Bioequivalence for Biological Products

Frequently Asked Questions in Bioequivalence



Appendix A: Statistical Tables

Appendix B: SAS Programs


Read More Show Less

Customer Reviews

Be the first to write a review
( 0 )
Rating Distribution

5 Star


4 Star


3 Star


2 Star


1 Star


Your Rating:

Your Name: Create a Pen Name or

Barnes & Review Rules

Our reader reviews allow you to share your comments on titles you liked, or didn't, with others. By submitting an online review, you are representing to Barnes & that all information contained in your review is original and accurate in all respects, and that the submission of such content by you and the posting of such content by Barnes & does not and will not violate the rights of any third party. Please follow the rules below to help ensure that your review can be posted.

Reviews by Our Customers Under the Age of 13

We highly value and respect everyone's opinion concerning the titles we offer. However, we cannot allow persons under the age of 13 to have accounts at or to post customer reviews. Please see our Terms of Use for more details.

What to exclude from your review:

Please do not write about reviews, commentary, or information posted on the product page. If you see any errors in the information on the product page, please send us an email.

Reviews should not contain any of the following:

  • - HTML tags, profanity, obscenities, vulgarities, or comments that defame anyone
  • - Time-sensitive information such as tour dates, signings, lectures, etc.
  • - Single-word reviews. Other people will read your review to discover why you liked or didn't like the title. Be descriptive.
  • - Comments focusing on the author or that may ruin the ending for others
  • - Phone numbers, addresses, URLs
  • - Pricing and availability information or alternative ordering information
  • - Advertisements or commercial solicitation


  • - By submitting a review, you grant to Barnes & and its sublicensees the royalty-free, perpetual, irrevocable right and license to use the review in accordance with the Barnes & Terms of Use.
  • - Barnes & reserves the right not to post any review -- particularly those that do not follow the terms and conditions of these Rules. Barnes & also reserves the right to remove any review at any time without notice.
  • - See Terms of Use for other conditions and disclaimers.
Search for Products You'd Like to Recommend

Recommend other products that relate to your review. Just search for them below and share!

Create a Pen Name

Your Pen Name is your unique identity on It will appear on the reviews you write and other website activities. Your Pen Name cannot be edited, changed or deleted once submitted.

Your Pen Name can be any combination of alphanumeric characters (plus - and _), and must be at least two characters long.

Continue Anonymously

    If you find inappropriate content, please report it to Barnes & Noble
    Why is this product inappropriate?
    Comments (optional)