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From Detection to Prediction: SAS for Pharmacovigilance and Proactive Risk Management

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27 out of 50 users found this white paper useful


Publisher SAS Institute
Publisher Registration Register to Access
Topics Data Mining - Analysis, Business Intelligence - Data Warehousing, Knowledge and Data Management Date added 09 Aug 2004
Downloads 93 Format 321.7KB PDF

Although the product development process is very demanding and thorough, it is impossible to detect all safety concerns during the clinical trial process. Pharmacovigilance is an important component of Food and Drug Administration regulations for risk management plans. Current methods in pharmacovigilance often use monitoring and simple analysis of safety signals after they have been detected in the postmarketing process. The cost of missing a safety signal or not detecting it before it affects the general population is great. To prevent adverse events and product recalls, life sciences companies must become predictive and proactive with pharmacovigilance. SAS has the technology and capability to apply predictive modeling to postmarketing data to be proactive in pharmacovigilance and help prevent recalls and human suffering.

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27 out of 50 users found this white paper useful


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