[Pharmacy in the 90's: the modern process of drug registration].
The 5 phases of the development of a drug are reviewed in the light of the modern scientific guide-lines. The needed documentation (master-file) and technical-scientific data are (and will be) constantly more demanding. Therefore, the drugs will undergo a hard selection. The Regulations for Marketing Authorizations, already of a high regulatory level, are increasingly in agreement. Therefore, the gap existing in the past among countries with a different technological evolution is filled. The measures of the Health Authorities before and after the authorization to the marketing of the medicinal specialties are always more systematic. Many procedures clearly pointing out the process of the study of a substances destined to become a drug (GMP - GLP - GCP - DMF) are now established on an international level. The drugs of the nineties will undergo a very hard selection, to warrant a positive risk-benefit balance and a profitable cost-benefit ratio. The compound under study are numbered in hundreds, whereas those which pass the screening and can be used as specialties are very few. The costs of development can be estimated in tens of billion liras and the times required on average are of about 10 years for each project. The attention of the scientists and the pharmaceutical companies is directed especially to the development of innovative drugs for the treatment of the most important diseases.
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D015195:Drug Design; D004345:Drug Industry / Q000639:trends; D007558:Italy; D007880:Legislation, Drug
Farmaci anni 90: ovvero i moderni processi per la registrazione sanitaria.