دانلود کتاب مبانی توسعه دارویی

This introductory text lays the foundation for explaining how pharmaceutical research is conducted and the context for how the pharmaceutical industry fits into the global healthcare environment. It begins with a brief review of the history of drug development and explains the phases of drug development in detail. The decision-making process, drug development milestones, and compound progression metrics are defined and explained with examples. Corporate structures are discussed, along with the role and function of the project team to facilitate development. The various contributors and sectors that participate in pharmaceutical research and development, in general, are identified as well as the emerging trends which are shaping the future of drug development. The various disciplines involved are highlighted along with an assessment of the complexity and risks associated across the various stages of development. Differences in the nature and scope of development programs due to the therapeutic area of interest as well as the associated costs and resources required are also explored via examples. As the pharmaceutical industry is constantly evolving in response to advances in science and technology as well as in response to an overall global healthcare economy that seeks to provide treatments to patients faster and cheaper, this text also provides some forward-looking analyses on current industry trends and economic indicators. In addition, attrition rates are discussed from both a historical perspective and in response to regulatory guidance, which has sought to improve this situation. It is clear that the era of the blockbuster drug has ended, and the sustainability of that approach is unlikely. Out of necessity, paradigms for drug development must likewise change for the benefit of both the industry and the patients that are depending on the industry to advance cures for a myriad of diseases.