ISSN: 2041-6792

Clinical Investigation

Drug Toxicology Developments

Traditional regulatory toxicology has developed sophisticated methods and methods to characterize the possible hazards and associated risks of potential drug candidates. However, this comparatively retrospective and descriptive approach has been deemed unsustainable in view of unacceptable attrition and issue rates in preclinical safety testing and clinical studies as well as ever-increasing safety expectations and requirements. Thus, supported expert knowledge, steps are taken to actively design safer drug candidates. This is mostly done by trying to avoid known structural or pharmacokinetic properties resulting in certain side effects. The situation is comparable to the crash testing of a finished automobile (regulatory toxicology), which leads to a completely new area of expertise in which researchers are charged with designing air bags and safety crush zones (investigative or discovery toxicology). However, in contrast to the car industry, it remains to be seen if early, active safety efforts lead to the same level of improvement. Despite the various activities within the regulatory and investigative toxicology area, one aspect remains unaddressed. There is no element in the preclinical safety package focusing directly on patients. All studies are conducted in healthy young animals and are, thus, primarily risk-assessment tools for healthy human subjects. However, many diseases are known to increase patients’ susceptibility to side effects.    

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