San Francisco Chapter of the American Statistical Association October Seminar



Dongmei Liu, Manager, Biostatistics, Gilead(Former mathematical statistician at FDA)


October 5th, 2015  4:30-6:00pm (4:30-5:00 pm networking/refreshment, 5:00-6:00pm presentation)


701B (2nd floor) N Shoreline Blvd, Mountain View, CA 94043.


An Example to Show Importance of Benefit/Risk Assessment in Drug Development




In July 2011, the Food and Drug Administration (FDA) approved Arcapta Neohaler (indacaterol maleate powder), a long-acting beta-agonist (LABA), at a dose of 75 μg once daily as a bronchodilator for patients with chronic obstructive pulmonary disease (COPD). Since the European Medicines Agency (EMA) had approved indacaterol at doses of 150 μg and 300 μg in 2009, one might question why the FDA selected a 75-μg dose. This talk is to summarize the statistical review on dose selection issue for this drug and answer the question why the FDA approved the 75-μg dose




To get to 701B (2nd floor) N Shoreline Blvd, Mountain View, CA 94043, the most convenient routes are from 101 or central express way and then get off onto N Shoreline Blvd. There are free parking spaces in the back of the building.