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

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 early stages of drug development programmes aim to prove a new drug’s safety by determining the safe dose range and identifying any potential side-effects. Phase I clinical trials in particular are intended to highlight key information related to the safety aspects of new therapeutics. A successful early stage clinical trial should be able to report on the drug’s interaction with another drug, as this can often have unpredictable consequences by increasing the magnitude of the effect of either drug or even creating new adverse effects that are not usually observed by either drug independently. 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.

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Author: Linda Hermans, Scientist and Product

Specialist, Cambridge Cognition

Cambridge Cognition are Silver sponsors at our Drug Safety US congress taking place on 22-23 April in Chicago. To find out more please click here

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