Drug safety evidence aggregation platforms are becoming a vital tool for pharmacovigilance departments at pharmaceutical manufacturers. Throughout this eBook, specific use cases for will be provided for a drug safety evidence aggregation platform designed for all functions within a drug safety department, including signal detection, safety science, and epidemiology.
Manuscripts by Advera Health authors published in academic journals
Many serious drug adverse events (AEs) only manifest well after regulatory approval. Therefore, the development of signaling methods to use with post-approval AE databases appears vital to comprehensively assess real-world drug safety. However, with millions of potential drug–AE pairs to analyze, the issue of focus is daunting.
Given the multiple limitations associated with relatively homogeneous preapproval clinical trials, inadequate data disclosures, slow reaction times from regulatory bodies, and deep-rooted bias against disclosing and publishing negative results, there is an acute need for the development of analytics that reflect drug safety in heterogeneous, real-world populations.
Most of the modern adverse event reporting into FAERS does not follow the pattern described by the ‘Weber Effect'. Modern FAERS reporting has improved greatly over the last decade and will be an increasingly important factor in determining the overall safety profile of FDA approved prescription drugs
“Stimulated reporting,” is the concept that public disclosure of a safety issue by the issuance of an FDA alert or warning, or the clustering of adverse event reports triggered by consumer-based “support group” and/or litigation, will result in substantially increased reporting rates for the affected drug. This publication refutes this widely held assumption
Publications from Roche and a case-control study suggest that there is no evidence, or plausible mechanism of action, to link neuropsychiatric adverseeventst oTamiflu (oseltamivir). Cochrane Collaborators, the BMJ ,and others,however, contend that many of Roche’s data remain unavailable.
Cholesterol management drugs known as statins are widely used and often well tolerated; however, a variety of muscle-related side effects can arise. We conducted a review of post-approval muscle and tendon AE reports in association with statin use, to assess differences within the drug class.
By Downloading this poster you will: Receive a comparison of pre-approval adverse event profiles, understand the post-marketing adverse event reports and disproportional reporting, and gain insight into post-approval estimated direct medical cost burdens