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PhRMA QT statistics expert team
The team was created in early 2002. The team
was chaired by Scott Patterson (GlaxoSmithKline) and Marylin Agin (Pfizer).
Objective
The expert team was created to comment on
key statistical points of the ICH
E14 guidance (Clinical Evaluation of QT/QTc Interval Prolongation
and Proarrhythmic Potential for Non-Antiarrhythmic Drugs). The
collective thoughts of the expert team formed the basis of the
white paper published in Drug Information Journal. Member list
Marilyn Agin (Pfizer), Rich Anziano (Pfizer),
Alex Dmitrienko (Lilly), Georg Ferber (Novartis), Steve Francom
(Pharmacia), Margarida Geraldes (BMS), Kalyan Ghosh (Merck), Mike
Hesney (Merck), Tracy Mills (Roche), Ron Menton (Wyeth), Walt
Offen (Lilly), Jaya Natarajan (J&J), Scott Patterson (GSK), Jay
Saoud (Aventis), Brian Smith (Lilly), Ramachandran Suresh (Schering
Plough), Nevine Zariffa (GSK).
Publications
Patterson, S., Agin, M., Anziano, R.,
Burgess, T., Chuang-Stein, C., Dmitrienko, A., Ferber, G., Geraldes,
M., Ghosh, K., Menton, R., Natarajan, J., Offen, W., Saoud, J.,
Smith, B., Suresh, R., Zariffa, N. (2005). Investigating drug-induced
QT and QTc prolongation in the clinic: A review of statistical
design and analysis considerations. Drug Information Journal.
39, 243-266.
This is the white paper prepared by the PhRMA QT
statistics expert team. This paper received the 2006 Donald E.
Francke Award for Overall Excellence (Drug Information Association).
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