Twenty-First Century Pharmaceutical Development, edited by Peter Blaisdell, takes a look on how key aspects of the drug development processes currently work and how they may be done in the future. The book is organized in such way to reflect the various functional disciplines involved in the development of drugs. This book reviews strategies with emphasis on issues critical for smaller drug companies. On discovery research it describes several current approaches to identify genes of interest and their functions.
This book provides an overview of pre-clinical research, both the current animal trails as well as describing promising new methods in vitro and in vivo that may reduce the need for traditional safety testing in animals. The role of applied statistics plays in clinical trail design is described in this book. Effective legal, marketing and regulatory strategies are described. The characteristics of patents on intellectual property along with an overview of infringement and inventorship are sufficiently elaborate.
A firm developing drugs or devices can outsource almost any part of the process from pre-clinical activities through marketing an approved product. This part is successfully played by Contract Research Organizations (CROs). While describing this aspect, a case study is also included with illustrations between a sponsor and a CRO during a developmental project.
In an era of increasing time and budget constraints, project management will play a vital role in tracking and managing project schedules and costs. This book describes the evolving role on project management.
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