Raising the Science Standard for New Drug Development.

      Аннотация: New drug development has sunk into a state of doldrums in spite of explosive advancement of basic research, especially in human genomics, and enormous investment from both government and industry. 2007 was the worst rate of new drug approvals in a quarter of a century in the U.S. experience. This book proposes raising the science standard for new drug approvals to end the "race to the bottom" the biopharmaceutical sectors are engaged in, and to enhance the role of the U.S. government in new drug development along the lines of the Manhattan Project and the Human Genome Project.

Ключевые слова: clinical trials, FDA, Ich, New drug approval, science standard, single subject research design (SSRD), new drug approvals