Development of searchable database for pre-clinical and clinical information of approved pharmaceuticals

In collaboration with the European Chemicals Agency (ECHA), we embarked on a pivotal project to enhance the way pharmaceutical data is accessed and analysed. Our primary goal was to develop a searchable database that draws from the comprehensive Drugs@FDA website, which houses information on pharmaceutical substances submitted for market authorisation by the US FDA. The focal point of this initiative was the new drug applications (NDAs) for new molecular entities (NMEs). These NDAs are particularly invaluable as they offer information of both nonclinical and clinical data. Given the absence of clinical studies on chemical substances under the REACH Regulation, our project pivoted towards the pharmaceutical domain, ensuring that valuable human data from both clinical trials and post-marketing experiences were efficiently harnessed. The resultant structured, searchable format crafted in our database and IUCLID format now stands as a robust platform for advanced correlation analyses, bridging the gap between in vitro/in vivo animal studies and human insights. Check also our dashboard as an example of the data’s content.