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As the first decade of the twenty-first century draws to an end, the arena of bioavailability and bioequivalence has generated a lot of scientific, statistical, and regulatory activities and issues from the pharmaceutical industry, health authorities, as well as academia, since the publication of the second edition of our book in 2000. In particular, a series of regulatory guidelines or guidances were issued by different health authorities in the world. In January 2001, the U.S. Food and Drug Administration (FDA) issued the guidance on Statistical Approaches to Establishing Bioequivalence. Six months later, in July 2001, the European Agency for the Evaluation of Medicinal Products (EMEA) issued the Note for Guidance on the Investigation of Bioavailability and Bioequivalence. In March 2003, the U.S. FDA released the guidance on Bioavailability and Bioequivalence Studies for Orally Administrated Drug Products—General Considerations. Later, the World Health Organization, in 2005, issued the draft revision of the guidelines on Multisource (Generic) Pharmaceutical Products: Registration Requirements to Establish Interchangeability. On the other hand, tremendous opportunities as well as challenges still lie ahead for bioavailability and bioequivalence in the twenty-first century because of breakthroughs in biotechnology and methodological research in medicine, pharmacokinetics, and statistics. In response to the challenges, upon the invitation of Professor R.B.D’Agostino, one of the co-editors of Statistics in Medicine, we were invited as guest editors for a special issue of 13 papers on individual bioequivalence that was published on October 30, 2000. In addition, the U.S. FDA issued a document on Critical Path Opportunities for Generic Products on May 1, 2007 to address emerging challenges and opportunities for generic drug products. The issues on the regulations and scientific issues of biosimilar products or follow-on biologics still remain unresolved. Consequently, there is an urgent need for the third edition of this book to provide a complete and overall presentation of the latest development of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology.
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