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[How to develop an anti-arrhythmia agent in 1990. The industrialist's viewpoint].

Authors
Type
Published Article
Journal
Archives des maladies du coeur et des vaisseaux
Publication Date
Volume
84 Spec No 2
Pages
63–66
Identifiers
PMID: 1669240
Source
Medline

Abstract

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.

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