Summary explore important tools for high quality work in pharmaceutical safety statistical methods for drug safety presents a wide variety of statistical approaches for analyzing pharmacoepidemiologic data. An important source of signals in drug safety has been and will continue to be the observations of clinicians who report adverse drug reactions adrs. Robert d gibbons university of chicago illinois usa anup k amatya new mexico state university las cruces usa statistical methods for drug safety. As noted in the institute of medicine report on the future of drug safety burke et al 2006 every day the food and drug administration fda works to balance expeditious access to drugs with concerns for safety consonant with its mission to protect and advance the public health. Meta analyses of drug safety should include appropriate statistical methods and assess the optimal information size to avoid type 2 errors they should evaluate outcome reporting biases and missing data to ensure reliable and accurate interpretation of findings regulatory and academic partnerships should be fostered to provide an independent and transparent evaluation of drug safety review
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