[Regulatory science for drug evaluation].
The regulatory science is a tool to utilize the fruit of academic science for the public. The regulatory science for drug evaluation is a tool to more effectively evaluate the risk/benefit balance of applied new drugs and enables to ensure faster accessibility to more effective and safer drugs for the public, and also a tool to accelerate the translational research, which leads the shaping of basic scientific discoveries into treatments, the process from scientific breakthrough to the availability of new, innovative medical therapies for patients. Finally, the author suggests that the collaboration of the industry, academia, and regulator is necessary and important to activate the regulatory science, which is the tool of drug evaluation and accelerates the translational research for new drug development.
Pharmaceuticals and Medical Devices Agency.
Satoshi
S
Toyoshima
D035843:Biomedical Research; D004341:Drug Evaluation / Q000379:methods*; D018570:Risk Assessment; D057170:Translational Research, Biomedical