Remaining on the cutting-edge of this rapidly evolving field, this unequaled resource has expanded more than 70% of its original entries to review amendments to regulatory requirements and recently developed statistical methods impacting the drug review/approval process and biopharmaceutical research and development.

Alerts specialists to current standards and best practices in clinical, laboratory, manufacturing, and statistical design, investigation, and analysis.

Eclipsing any other competing source, the Second Edition offers more than 5800 references, 150 contributors, and nearly 3000 equations, tables, and figures for thorough exploration of emerging technologies, concepts, and trends vital to the biopharmaceutical industry.

This favored reference offers over 65 new sections on subjects including

1. in vitro bioequivalence testing
2. in vitro dissolution profile comparison
3. reproducibility and generalizability probability in clinical research
4. bridging studies
5. MedDRA
6. vaccine clinical trials
7. medical devices

Reviews

"I was delighted by the information and insight that was available in the sections of the Encyclopedia….The authors demonstrate their expertise and knowledge in well written material that covers each of the topics fully….These authors and the editors are to be congratulated for a job well done."
Ralph Buncher
Fellow, the American Statistical Association and the American College of Epidemiology
Professor of Biostatistics
University of Cincinnati - Ohio, U.S.A.


"…an essential desktop reference….fine for taking some pertinent topic in biostatistics and quickly learning about it."
Technometrics


"…an impressively presented hardback….you receive plenty for your money."
The Statistician


"…Most of the contributors to the encyclopedia are biostatisticians who have extensive practical experience in biopharmaceutical research and development. However, the publishers have made each entry simple enough for the untrained to understand. This reference covers all key topics for evaluation of data at critical stages in the pharmaceutical research and development process, highlighting the vital areas of statistical design and regulatory requirements…This book is an essential to those working in pharmaceutical fields. It would be an excellent addition to academic institutions with pharmacy programs……provides a comprehensive and unified presentation…covers all key topics…This book is an essential…It would be an excellent addition to academic institutions with pharmacy programs."
E-Streams


"The contributors are well known…Recommended."
CHOICE

Preface

In recent years, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines for the treatment of certain diseases that are severe and/or life-threatening. Biopharmaceutical statistics plays an extremely important role in ensuring not only the efficacy and safety of the medicine under investigation but also that the pharmaceutical product possesses good drug characteristics such as identity, strength, purity, quality, stability, and reproducibility. As indicated in the first edition, the purpose of this encyclopedia is to provide a comprehensive and unified presentation of designs and analyses utilized at different stages of biopharmaceutical research and development and to give a well-balanced summary of current regulatory requirements and recently developed statistical methods in this area. Since the first edition was published in 2000, this encyclopedia has been well received by pharmaceutical scientists/researchers and is now widely used as a reference source in biopharmaceutical research. It is our continued goal to provide a more complete and comprehensive encyclopedia in the area of biopharmaceutical statistics. The second edition was proposed to include more topics and to include an online version for easy access by pharmaceutical scientists/researchers.

The second edition can be distinguished from the first one in three ways. First, we have revised and/or updated entries to reflect changes in regulatory requirements for the drug review/approval process and recent developments in statistical design and methodology in biopharmaceutical research. Second, we have included additional topics to provide a more complete and comprehensive reference source. To name just a few, the second edition includes new and exciting topics such as in vitro bioequivalence testing, in vitro dissolution profile comparison, reproducibility probability in clinical research, generalizability probability in clinical research, bridging studies, MedDRA, diagnostic imaging, medical devices, and vaccine clinical trials. Finally, the second edition of this encyclopedia is available online (www.dekker.com).

The traditional hardbound volume has the articles arranged alphabetically. The online version couples the content of the hardcopy with a powerful search engine. The online version supports publication of full-color graphics. Online subscribers will be able to browse the Table of Contents, look up articles by authors' last names or keywords, view articles in HTML or PDF format, or utilize the search engine to query the complete online version of the encyclopedia. It is anticipated that at least 10% new content will be added annually (through online quarterly updates) to ensure that the encyclopedia will remain on the cutting edge of rapidly evolving fields.

The first edition of this encyclopedia included 72 entries. In the second edition, more than 70% of the existing entries were updated or revised. An additional 69 new entries were written by experts in their respective fields. As a result, the second edition consists of 141 entries.

Although the contributors are mostly biostatisticians who have extensive practical experience in biopharmaceutical research and development, we have attempted to make each entry self-contained and self-explanatory to a reader who is not an expert in the subject matter of each topic. As a result, this encyclopedia will benefit pharmaceutical scientists/researchers from the pharmaceutical industry, regulatory agencies, and academia by serving as an extremely useful reference source in biopharmaceutical research.

From Marcel Dekker, Inc., I would like to thank Russell Dekker and Maria Allegra, for providing me with the opportunity to work on this edition, and Carolyn Hall for her outstanding efforts in preparing this edition, including online publication. I am deeply indebted to the U.S. Food and Drug Administration (FDA) and many major pharmaceutical companies, including Merck, Eli Lilly, and Pfizer for their support. I would like to express my gratitude to K. Haston of StatPlus, Inc., for her administrative assistance during the process of the preparation of this edition.

Finally, the views expressed are those of the contributors and not necessarily those of their respective companies or organizations. Any comments and suggestions will be very much appreciated for the preparation of quarterly updates for the online version and/or future editions of this encyclopedia.

Shein-Chung Chow