January 2008
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The safety concepts applied in the development of new drugs are based on individual tests of each new chemical entity. The applicable law is codified in the German Medicines Act (AMG). Alongside animal experimentation (pharmacology and toxicology), efficacy and tolerability are evaluated in clinical trials conducted with healthy human volunteers and patients. The population exposure is calculated in such a way that acute effects with a probability of 0.1 % are displayed; rarer risks are usually not detected in clinical trials prior to the approval of new drugs. Medical devices are tested regarding their conformity with predefined safety standards and power intensities. Adequate long term data are still missing in both cases at the time of market launch. Consequently, it is necessary to report and assess risks during actual use.