Dept of Pharmacy, Saarland University, 66123 Saarbrücken, Germany.
Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Helmholtz Centre for Infection Research (HZI), Saarland University, 66123 Saarbrücken, Germany.
Drug Discov Today. 2018 Dec;23(12):1962-1973. doi: 10.1016/j.drudis.2018.10.008. Epub 2018 Oct 17.
The pharmaceutical industry invests enormous amounts of resources (>€1 billion and >10years) in the development of new products. External factors such as intensifying foreign competition and greater regulatory demands can negatively affect the profit margin, whereas the R&D productivity diminishes. To stay competitive and to maintain high R&D capabilities for developing new medicinal products, companies must make smart investment decisions to maximize their return on investment. Consequently, the entire lifecycle of a medicinal product must be effectively managed to ensure a sustained development through commercialization. This review critically assesses the current situation and the associated management strategies throughout the lifecycle of a medicinal product.
制药行业在新产品开发上投入了大量资源（超过 10 亿欧元和 10 年以上）。外部因素如加剧的国际竞争和更高的监管要求可能会对利润率产生负面影响，而研发生产力则会下降。为了保持竞争力并维持开发新药的高研发能力，公司必须做出明智的投资决策，以实现投资回报最大化。因此，必须有效管理药品的整个生命周期，以确保通过商业化实现可持续发展。本文批判性地评估了药品整个生命周期的现状和相关管理策略。
