• Authorline (AL): What was your motivation for writing this book?
• Alex Dmitrienko (AD): This book is conceptually similar to our recently published SAS Press book (Analysis of Clinical Trials Using SAS: A Practical Guide) in that it was written to bridge the existing gap between statistical methodology and statistical applications in pharmaceutical drug development. To achieve this goal, each of the 14 chapters in this book (with the exception of the introductory chapter) includes three key elements: discussions of relevant statistical methodology, case studies, and reviews of software implementation in SAS.
• Christy Chuang-Stein (CCS): One distinctive feature of this book is the attention paid to statistical methods in support of nonclinical and early clinical testing of a pharmaceutical product. This focus is clearly needed since these methods are rarely addressed in existing books on statistics.

• (AL): Who are you targeting with your book?
• (AD): The main audience includes statisticians and other SAS users in the pharmaceutical and biotechnology industries, contract research organizations, and academic/government institutions that conduct health-care related research.
• (CCS): The book will also be useful to researchers in pharmaceutical and biotech industries who are interested in statistical principles applicable to many research and development activities.

• (AL): What features of the book are you especially pleased with?
• (CCS): As we mentioned earlier, we are particularly pleased with the focus on statistical applications in nonclinical and early clinical testing of pharmaceutical products.

• (AL): How will your book benefit SAS users?
• (AD): I will list several distinctive features of our book that I think will make the book attractive to a broad group of readers:
  • The book deals with key statistical problems arising at various stages of pharmaceutical drug development.
  • The book offers a lot of useful practical advice, including technical issues and software implementation issues.
  • The book features a large number of case studies that illustrate the described statistical methods and drive important messages home.

• (AL): Did you learn anything while writing this book that would be important for other authors to know?
• (AD): Managing a project of this kind (14 chapters, 42 contributors) takes a different set of skills compared to simply writing a book on your own (which is obviously quite challenging as well). There are an increasing number of edited books aimed at the pharmaceutical industry (and other areas). It is probably not surprising since books of this kind help readers familiarize themselves with and keep track of recent developments in a large number of topics. They offer a one-stop shopping solution. I would encourage other authors to keep this option in mind.
• (CCS): If the author plans to invite many contributors, it is important to decide on common notations and a similar writing style to be followed by the contributors. It is also important to recognize early on possible overlap in materials to avoid rework at the last minute.

• (AL): How did you decide to publish with SAS?
• (AD): We really enjoyed working with SAS Press on Analysis of Clinical Trials Using SAS: A Practical Guide and, since this book can be considered an extension of our first book, it seemed natural to submit the book proposal to SAS Press.

• (AL): Your book will be going to the printer in just a few weeks. How does it feel to be in the home stretch of such a long project?
• (AD): It was great working with a diverse and very talented group of contributors. I would like to thank all of them for their terrific work.
• (CCS): It is exciting to know that several years' work has come to fruition. I am sure the contributors will be thrilled to see their work in print also.

• (AL): What advice would you give to potential authors?
• (AD): To paraphrase Thomas Edison, writing a book takes 99% perspiration (that is, planning) and 1% inspiration (that is, actual writing).
• (CCS): To store up a heavy dose of tenacity and perseverance.

• (AL): How were you able to balance your time between your career and writing this book?
• (AD): Compared to our first SAS Press book, this one did not take as much of my time because I served mainly as an editor (I contributed to only one chapter). However, it did take a concentrated effort to get things going at first and maintain the right pace throughout this three-year project. It sometimes felt like a full-time job, and I would like to take this opportunity to thank my family for their support and for helping me set aside time to move from milestone to milestone.

• (AL): When you aren't writing, how do you like to spend your free time?
• (AD): I spend most of my time with my family and extended family (my wife's sister lives with her family very close to us).

Alex Dmitrienko, Ph.D., is Principal Research Scientist, Eli Lilly and Company. He has been actively involved in biostatistical research and has published papers on multiple testing, group sequential inferences, and analysis of categorical data with clinical trial applications. Alex co-authored a recently published SAS Press book, Analysis of Clinical Trials Using SAS: A Practical Guide. His other interests include software implementation of new and existing statistical methods.

Ralph B. D'Agostino, Sr., Ph.D., is Professor of Mathematics/Statistics and Public Health at Boston University. Ralph has published over 400 papers on clinical trials, epidemiology, health services, and statistical methods, and he is coauthor/editor of 7 books. He has been an advisor to the FDA since 1974 and has consulted extensively with pharmaceutical companies around the world.