A proposal to improve the supply of orphan drugs
A proposal to improve the supply of orphan drugs
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DOI：
10.1006/phrs.1999.0644
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发表时间：
2000-07-01
影响因子：
9.3
通讯作者：
Montanari, L
中科院分区：
文献类型：
--
作者：
Minghetti, P;Giudici, EM;Montanari, L
工业药品并不总是可用于治疗某些特定患者或疾病。例如，对孤儿药、被忽视的剂量或给药途径以及患者对赋形剂的敏感性进行适当的研究，可能会在这方面产生令人感兴趣的结果。在美国，关于孤儿药的具体立法可追溯到1983年;在欧洲联盟，目前正在研究有关条例。在采取适当的鼓励措施之后，孤儿药的工业生产可能会得到改善。新的法规还应注意被忽视的剂量，并刺激盖伦产品的制备，例如，将一些关于孤儿药的专著纳入药典和国家处方集。事实上，在社区和医院药房按照医疗处方或药典或官方处方集的处方制备的药物和药用制剂可以代表有效的替代品。本文将讨论美国和日本的法规，欧洲的情况，对该行业可能的激励措施以及盖伦产品的作用。(C)北京大学出版社.
Industrial medicinal products are not always available for the treatment of some specific patients or diseases. Appropriate research on orphan drugs, neglected doses or administration routes and patients' sensitivity to excipients, as an example, might lead to interesting results in this respect. In the United States, a specific legislation on orphan drugs dates back to 1983; in the European Union, regulations are currently being studied. The industrial production of orphan drugs might be improved following the adoption of adequate incentives. New regulations should also take care of neglected doses, and stimulate the preparation of galenic products, as an example by including a number of monographs on orphan drugs in Pharmacopoeias and National Formularies. As a matter of fact, magistral and officinal preparations made in community and hospital pharmacies in accordance with a medical prescription or with the prescription of a Pharmacopoeia or an Official Formulary, can represent an effective alternative, In this paper, the regulations enforced in the USA and Japan, the European situation, possible incentives to the industry and the role of galenic products will be discussed. (C) 2000 Academic Press.