System Dynamics Modeling for FDA Regulation Effect of Pharmaceutical Industry

제약산업에서 FDA규제 영향에 관한 시스템 다이내믹스 모델링: FDA규제가 R&D비용에 미치는 영향을 중심으로

This research studies effect of FDA regulations in pharmaceutical industry on new drug development. System dynamics is implemented to demonstrate dynamic relationship between FDA regulations and R&D costs, firm's profits, sales. This research is focused on clinical trials of new medical entity process 50~60% portion of total development cost. Simulation results say that firm's profit is more sensitive to increasing the regulation than alleviating the regulation and effect of regulation policy make different result depending on the intensity of regulation and policy direction. Our simulation model provides the instrumental means for the policy makers and strategic decision in pharmaceutical industry.