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At first glance safety pharmacology and immunotoxicology do not seem to be key issues in the development of a new active ingredient. Usually the results of different subchronic and chronic toxicity studies are of very high significance, representing milestones that affect related decisions in the various stages of a drug development programme. On the other hand, the results of marketed products using pharmacovigilance have demonstrated that unexpected adverse reactions concerning the cardiovascular system and the immune system have been recorded in patient populations that were not detected and evaluated during the drug development programme.
Therefore, the topics of safety pharmacology and immunotoxicology are obtaining an increasing level of importance by the licensing authorities in recent years, and must be considered very carefully during the drug development programme - especially for the compilation and submission of the registration documentation. The growing interest of the licensing authorities is also reflected by the discussion and establishment of new guidelines and amendments to existing guidelines, which compile and publish the actual positions and experiences in this field. |
