Haigler H J, Cott J M, Rudorfer M V, Schoenfeld R E, Potter W Z, Vitiello B, Everist H D
National Institute of Mental Health, Rockville, MD 20857.
Psychopharmacol Bull. 1993;29(2):241-7.
The Psychotherapeutic Medications Development Program (PMDP) of the National Institute of Mental Health was established in 1990. The purpose of the PMDP is to improve, enhance, and speed the development of new medications and improve the therapeutic usefulness of existing medications for the treatment of mental illness. The PMDP will fulfill this mission by implementing four initiatives. In the drug discovery and development initiative, the PMDP will aid in the development of promising new drugs. This initiative will also include improving the therapeutic usefulness of existing medications. In the technology transfer initiative, PMDP will improve the technology transfer from academic and government researchers to the pharmaceutical industry; improve the dissemination of information concerning technology transfer opportunities as it pertains to psychotherapeutic medications; and enhance technology transfer by acting as a broker to bring interested parties together. For the third initiative, the PMDP will develop and maintain a capability to clinically evaluate psychotherapeutic medications. The PMDP will also act to facilitate the development and testing of new concepts and models of mental illness. There is a detailed description of the steps that are involved in developing a new chemical entity (NCE) from the conceptual stage to a medication that is approved for the treatment of a particular illness. The pharmaceutical industry estimates that this medication development process costs $238 million.
美国国立精神卫生研究所的心理治疗药物开发项目(PMDP)成立于1990年。PMDP的目的是改进、加强并加速新型药物的开发,提高现有药物在治疗精神疾病方面的治疗效用。PMDP将通过实施四项举措来完成这一使命。在药物发现与开发举措方面,PMDP将助力有前景的新药研发。该举措还将包括提高现有药物的治疗效用。在技术转让举措方面,PMDP将改善从学术和政府研究人员到制药行业的技术转让;改善与心理治疗药物相关的技术转让机会的信息传播;并通过充当促成相关方汇聚的中介来加强技术转让。对于第三项举措,PMDP将开发并保持临床评估心理治疗药物的能力。PMDP还将促进精神疾病新概念和新模型的开发与测试。文中详细描述了从概念阶段到获批用于治疗特定疾病的药物这一过程中,开发新化学实体(NCE)所涉及的步骤。制药行业估计,这一药物开发过程耗资2.38亿美元。