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Drug Safety Expert

FDA Drug Safety Expert and FDA AERS/FAERS Expert

As a drug safety expert, Dr. Gortler is familiar with the drug developement process of evaluating new and established drugs for safety signals. New Drugs are tested in a limited sample population which should accurately represent the diverse population of patients in the United States. Testing drugs in a specific, non-diverse population, such as in an Asian population, could change the dose or the metabolization characteristics, or even the dose of the drug being tested. Likewise, different Asian populations (Chinese versus Korean versus Japanese populations) have been know to metabolize drugs remarkably differently, which could require a dosage adjustment for drugs that have a narrow safety window. For this reason, anywhere between 20% to >50% of a Phase 3 population should include the proposed dosing population in the United States.

In addition to being a drug safety expert for new drugs or drugs currently in development, Dr. Gortler is an specialist in the FDA's AERS database. FDA AERS (also knows as 'FAERS'), or the Adverse Event Reporting System, has been collecting adverse events of drugs which have already been approved. The accumulated FDA AERS database contains adverse drug events from every single U.S. marketed since its inception in 1997. It is run by the FDA and is a central depot of adverse events from many different sources including, physicians, pharmacists, nurses, drug companies, lawyers or the lay public. A special request must be made to the FDA in order to access their FDA AERS database, and analysis of FDA AERS data requires special skills. FDA AERS findings findings must be examined carefully by a drug safety specialist who is familiar with FDA AERS reporting and cataloging methods.

To consult with an experienced FDA expert at The Georgetown University School of Medicine, please visit: georgetown.edu/faculty/dg298/.

Georgetown University37th and O Streets, N.W., Washington D.C. 20057(202) 687.0100

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