Central Nervous System

Most of the adverse drug effects relating to the nervous system impact on the quality of life rather than the risk to life (e.g., lethargy, anorexia, insomnia, personality changes, and nausea). There are, however, some serious life-threatening adverse effects involving the nervous system (e.g., loss of consciousness and convulsions). Some of these reflect the fact that the nervous system controls the other two vital organ systems for that CNS impairment could be fatal (e.g., decreased...

Predictive Value of Non Clinical Safety Pharmacology Testing to Humans

It is difficult to answer the question Are non-clinical safety pharmacology tests predictive of side effects in humans Primarily because hard evidence is not readily available in the public domain, if an NCE has an effect in a non-clinical test, there may be limited information in the public domain, as the result may have precluded clinical development and therefore no apparent value in communicating this information. If there has been no effect in a non-clinical test, and likewise no effect in...