About the Book
This book provides an overview of how key aspects of
the current drug development process and presents ideas as to how the process
may work in the future. The book is organized to reflect the various functional
disciplines involved in the development of drugs. Although some disciplines,
such as basic research, are likely to experience great changes in the next few
decades, all functional areas are evolving as the advances in basic science
allow fundamental health issues to be addressed. The early decades of the
twenty-first century will almost certainly see continued success in turning
basic biological research into exciting pharmaceutical products. Improvements
in the drug development process described in this book will be critical in
achieving this goal.
• Financing strategies with a particular emphasis on
issues critical for smaller drug companies.
• Managing research efficiently without stifling
• Biostatistics to provide a statistical perspective on
trial structure, inclusion of control groups, randomization, and sizing of a
• Implementation of effective legal, marketing and
• New factors affecting the twenty-first century
• Functions of formulations.
• Drug and device outsourcing through Contract Research
• The evolving role of project management.
processes and future trends for diagnostic and medical device development.