Indroduction

BABE Solution 2008 developed by the PharmaSoftware Solutions, Inc is intended to be the first software package that devoted to the design and analysis of bioavailability (BA)/bioequivalence (BE) studies. BABE Solution 2008 provides statistical analysis for both in vivo bioequivalence and in vitro bioequivalence studies. It is our goal to provide pharmaceutical scientists and biostatisticians a state-of-the-art and user-friendly software for assessment of both in vivo and in vitro bioequivalence in pharmaceutical research and development.

This software consists of two modules: In Vivo ABE (average BE) and In Vitro BE. It provides statistical analysis for a standard two-sequence, two-period (2x2) crossover design for assessment of in vivo ABE. Under the standard 2x2 crossover design, bioequivalence assessment and tests for the period effect, the direct drug effect, and the carryover effects are provided. However, it does not provide statistical inference on the interactions among these effects and the interactions between fixed and random effects.

Developed base on best-seller

BABE Solution 2008 was developed based on the third edition of the book entitled Design and Analysis of Bioavailability and Bioequivalence Studies by Shein-Chung Chow and Jen-pei Liu, which is one of the best sellers at Amazon.com. As indicated in the preface of the third edition of this book, it provides a complete and an overall comprehensive presentation of the latest development in the area of bioavailability and bioequivalence. Regulatory requirements and guidances, scientific/practical issues, and statistical methodology are discussed in details. BA/BE Solution 2008 has successfully implemented the assessment of both in vivo ABE and in vitro BE described in this book.