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Conducting a clinical safety review in drug development: the regulatory environment

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Regulatory bodies have increased the pressure on pharmaceutical companies to measure and monitor the risk of cognitive adverse events associated with investigational treatments. At the same time, companies are becoming aware that monitoring the cognitive properties of investigational drugs can help minimize the risk of late stage failure in drug differentiation.

 

The pharmacokinetics of a compound and its actions in the body should be established, as well as its tolerated safe dose range with minimal side effects. Furthermore, the acceptability of the compound’s toxicity and reliability to target the appropriate biological processes must also be determined