Impact of Pharmacometric Analyses on New Drug Approval and Labeling
Decisions
by
Dr. Joo-Yeon Lee
Pharmacometric Reviewer
Division of Pharmacometrics, OCP/CDER/FDA
March 20, 2012
1:00 - 2:00 pm EDT
In this webinar, Dr. Joo-Yeon Lee will discuss a recent published article:
Impact of pharmacometric analyses on new drug approval and labelling
decisions: a review of 198 submissions between 2000 and 2008.
Lee JY, Garnett CE, Gobburu JV, Bhattaram VA, Brar S, Earp JC, Jadhav PR,
Krudys K, Lesko LJ, Li F, Liu J, Madabushi R, Marathe A, Mehrotra N, Tornoe
C, Wang Y, Zhu H.
Clin Pharmacokinet. 2011 Oct 1;50(10):627-35.
A short abstract of the presentation will be available on Rosa's webinar
website shortly.
The purpose of the "Impact" series is to foster the use of M&S activities in
all phases of drug development by illustrating the advantages and enhancing
the applicability of M&S in product discovery, development, and marketing
programs. The series is intended for drug development project team members
from discovery to phase 4 clinical trials. This includes pharmacologists,
ADME scientists, PK/PD modelers, clinical pharmacologists, clinical
development team members, regulatory affairs specialists, and other
interested professionals.
Register for this free webinar at www.rosaandco.com/webinar. After
registering you will receive a confirmation email containing information
about joining the webinar. More information about the webinar series, an
archive of past webinars, and a list of future webinar speakers may be found
at www.rosaandco.com/webinar.
Please allow 5-10 minutes for a Java applet to be installed on your computer
prior to joining our webinar series for the first time.
Toufigh Gordi, PhD
President, PK/PD and Clinical Pharmacology Services
Rosa & Co. LLC: www.rosaandco.com http://www.tgordi.com/
E-mail: [email protected] <mailto:[email protected]>
Tel.: 408-480-7314
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