Elsevier, Novartis Collaborate on Drug Development Safety Risk Tool
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Global life sciences information analytics provider Elsevier announced a collaboration with Novartis to develop a safety margin risk assessment prediction tool, largely using Elsevier’s PharmaPendium data. The data, which includes searchable FDA and EMA drug approval documentation and packages (including Adverse Events Reports and FDA Advisory Committee meetings), and comparative drug safety, pharmacokinetic, efficacy, and metabolizing enzyme and transporter data, will be used to predict and better justify earlier in the process target selections for development related to human safety, interpretation of clinical significance, and early submission to monitor and mitigate safety risks throughout clinical drug development.
