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New Regulatory Aspects on Safety Pharmacology and Immunotoxicology

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.


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By Professor Dr Ruediger Haecker, International Drug Regulatory Affairs Expert at RCC Ltd
Professor Dr Ruediger Haecker received his MD and PhD in Medicine from the Medical Academy in Magdeburg, Germany. He is a Certified Specialist in Biochemistry and a Fellow of the German Society of Molecular Biology and Biochemistry. During his university career Professor Haecker was appointed Assistant Professor for Pathological Biochemistry at the Medical Academy Dresden, Germany, and University Professor for Biochemistry at the 'Forschungsinstitut fьr Kцrperkultur und Sport' in Leipzig, Germany. At present he is working as an expert at RCC Ltd on the fields of international drug regulatory affairs, project management of preclinical and clinical research, and product development.

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Dr Ruediger Haecker
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