TL4: Innovated Design for First Time in Human Study
*Yu Lou, Glaxosmithkline Keywords: In this roundtable session, participates will join the discussion and share information for the FTIH trial design. The focus points of the discussion will include the following aspects: 1) How to identify the right initial doses; 2) how to manage the unexpected results; 3) how to escalate the doses; 4) if we should use Bayesian method to predict the dose and drug exposure; and 5) strategies for dose escaltion trials for more than one drug; 6) any other related topics.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC