San
Francisco Chapter of the American Statistical Association October Seminar
Speaker: |
Dongmei Liu, Manager, Biostatistics, Gilead(Former mathematical statistician at FDA) |
Time: |
October
5th, 2015 4:30-6:00pm (4:30-5:00 pm
networking/refreshment, 5:00-6:00pm presentation) |
Location: |
701B
(2nd floor) N Shoreline Blvd, Mountain View, CA 94043. |
Title: |
An
Example to Show Importance of Benefit/Risk Assessment in Drug Development |
Abstract:
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.
Directions:
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.