Introduction: The aim of the present work is to evaluate the efficacy and safety data used by the European Medicines Agency (EMEA) between 1995 and June 2006 to approve new immunosuppressive drugs with indications in solid organ transplantation.
Materials And Methods: The information about the approval of new agents was retrieved mainly from the European Public Assessment Report (EPAR) and Summary of Product Characteristics (SPC) on the EMEA web site. The design, type of control, primary endpoints, duration of follow-up, and safety profile of pivotal trials were examined.
Epidemiological and experimental studies have indicated that consumption of more n-3 long-chain polyunsaturated fatty acids may reduce the risk for a variety of diseases, including cardiovascular, neurological and immunological disorders, diabetes and cancer. This article focuses on the role of marine n-3 long-chain polyunsaturated fatty acids in brain functions, including the development of the central nervous system and neurological disorders. An overview of the major animal studies and clinical trials is provided here, focusing on fatty acid supplementation during pregnancy and infancy, and prevention and management of Alzheimer's disease, schizophrenia, depression and attention deficit hyperactive disorder.
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