自1960年以來,美國FDA推出的基礎研究-發(fā)現(xiàn)-設計-臨床前開發(fā)-臨床研究等過程的新藥研發(fā)的轉化研究,這種"轉化研究"的"萬里挑一"的模式,可以說是最早的"轉化研究",對近50年的新藥發(fā)展起了積極作用。隨著生命科學研究的發(fā)展及成果的應用,轉化研究得到快速發(fā)展,轉換醫(yī)學模式成為國際醫(yī)學健康領域的新概念和研究模式。在美國2010年提出"精準醫(yī)學"概念之后,奧巴馬在他的國情咨文中提出了"精確醫(yī)學"計劃,希望更接近治愈癌癥和糖尿病等疾病,希望將以基因為特點的大數據信息用于精準個體化藥物治療。"精準醫(yī)學"作為醫(yī)學的未來是人類醫(yī)學的變革,長期目標是為實現(xiàn)多種疾病的治愈提供有價值的信息。基于精準醫(yī)療四要素中"精確、準時、共享、個體化",筆者提出"精準藥學"的概念,希望它在實現(xiàn)"精準醫(yī)療"中發(fā)揮重要的作用,而且具有不同于"精準醫(yī)學"的研究目標和研究特征。"精準藥物"治療只有實現(xiàn)"精準診斷"的基礎上,醫(yī)療應用相關的"精準藥物"才能提出"精準治療方案",才能實現(xiàn)精準的個體化治療。在"大數據"時代,基因組學是精準醫(yī)學和精準藥學的共同基礎。但藥物研發(fā)中可以認為與健康人和病人的基因有關,更與疾病的病因有關,但有些功能性疾病和病毒、細菌、寄生蟲等感染性疾病的治療還與它們的感染、復制及其酶和蛋白等生化過程有關,也與藥物的制劑技術和組合有關。因此需要更廣闊的知識和視野去認識研發(fā)的難度和治療的精準性,才能開發(fā)出療效更好、更安全、更便利、更經濟的新藥。

Since the 1960s, the USA-FDA launched a mode on new drug research and development (R&D) by evaluation process based on discovery, design, preclinical research, and clinical development. This "one in a million" is a "translational research" and used for nearly 50 years. It played an active role in the R&D of new drugs. With the development and application of life science in medical research, translational research developed rapidly, thereby the medical model became a new concept and research model in international medical and health field. After the United States put forward the "precision medicine" concept, US President Barack Obama proposed a "precision medicine" plan in the State Union, and used this plan in the treatment of cancer and diabetes and other diseases, and hoped the big data information would be applied for precision drug individualized therapy. As the future development of medicine, "precision medicine" will change human medicine, and long-term goal is to achieve a variety of diseases of valuable information. Based on the four elements in precision medicine such as "accurate, timely, shared, and individual", author proposes the concept of "precision pharmacy" in this paper, and wants it to achieve "precision medicine" playing an important role, but having difference with "precision medicine" in research objectives and research characteristics. "precision diagnosis" is base to in individualized treatment, the application of "precision diagnosis" and "precise drugs" in order to achieve accurate medical therapy. In the "big data" era, genomics is common ground precision medicine and precision pharmacy. However, drug development and patient can be considered healthy genes, but also with the etiology of the disease related, but treating some functional diseases and infection diseases (such as viruses, bacteria, parasites, and other infectious diseases, but also with their infection), the replication and enzyme and protein and other biochemical processes. Additionally, the treatment is yet related with preparation techniques and combinations of drugs. So just we need a broader understanding the difficulty and having a vision in order to developsafer, more convenient, and more economical drugs with better efficacy for precision treatment.