[How to develop an anti-arrhythmia agent in 1990. The industrialist's viewpoint].
For the industrialist, the development of an antiarrhythmic drug is a long, high risk program which requires an important investment. The clinical program comprises two essential stages: an early stage, the object of which is to define the pharmacological profile of the product and to decide whether complete development is worthwhile; a stage of preparation of a dossier of registration based on the claimed indications and which must conform to international norms. There is a contrast between the importance of statutory demands which increase the cost of development and the size of the market. This might penalise the development of original and effective antiarrhythmic agents whereas the need for this type of product remains high.
Roland
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Rhône-Poulenc Santé, Antony.
D000889:Anti-Arrhythmia Agents / Q000138:chemical synthesis* / Q000493:pharmacokinetics / Q000494:pharmacology; D004282:Documentation; D004305:Dose-Response Relationship, Drug; D016527:Drug Costs; D004345:Drug Industry / Q000191:economics; D006801:Humans; D007880:Legislation, Drug
D000889:Anti-Arrhythmia Agents
Comment développer un antiarythmique en 1990. Le point de vue d'un industriel.