Description
As indicated by the first part of its title, New Drug Development, this book provides an overview of the wide spectrum of activities involved in developing a new therapeutic drug. This spectrum starts with the initial stages of identifying a potentially useful drug candidate and concludes with the detailed monitoring of the drug’s safety after it has been approved for marketing and is being prescribed for a large number of patients throughout the country. In between, it includes lead optimization, nonclinical and clinical evaluations of the drug’s safety and efficacy profiles, and manufacturing considerations. The second part of the book’s title, Design, Methodology, and Analysis, indicates the book’s focus on the collection, analysis, and interpretation of numerical representations of information throughout this drug development process.
The book is written with two groups of readers in mind. The first is entrylevel professionals in the pharmaceutical, biotechnology, and contract research organization industries and seasoned clinical research professionals who wish to refresh their knowledge in areas outside their immediate area of expertise. The second is students of clinical research, pharmacy, medicine, and allied health professions.
For the first audience, the book provides an introduction to new drug development and a core reference for discussions you will have with many members of study teams with whom you will work. These include professional statisticians and biomedical data scientists, clinical research associates, clinical monitors, clinical trial investigators, clinical trial administrators, managers, and coordinators, project managers, data managers, clinical scientists, regulatory affairs professionals, clinical operations specialists, medical writers, nurses, pharmacists, and medical safety officers. As well as becoming an expert at your own job, you will benefit greatly from being able to converse with all of these colleagues, and you will therefore become a much more valuable employee to your company.
For professors who may wish to consider using this book as a student textbook, several comments are appropriate. First, the book is the result of a course I teach in the Master of Science in Clinical Research degree program offered by Campbell University School of Pharmacy’s Department of Clinical Research. Given the department’s location in North Carolina’s Research Triangle Park, next to world class pharmaceutical and biotechnology companies and contract research organizations, study design and analysis are discussed in the context of pharmaceutical clinical trials. The fourteen chapters fit well with this semesterlong course. Second, the vast majority of references are books and book chapters, and these provide easily accessible sources of further information and resources for more detailed study. In addition, a list of Additional Resources for Training Executives and Professors is provided in the Appendix, indicating several books that may be particularly helpful as supplementary materials for lectures or may be designated as recommended additional reading for students. Third, PowerPoint slides for teaching support are available as detailed at the end of this preface