Presentations Annual Meeting 2005
Session I: Why do we need Phase I studies?
W. Seifert, Berlin
Is-Phase-I-useful-Seifert 01.pdf(415 kB)
Is Phase I useful?
H. Fuder, Mulhouse
Healthy-volunteers-or-patients-Fuder 01.pdf(4.0 MB)
Healthy volunteers or patients as target population in Phase I trials?
H. Caplain, Paris
Stop-dose-escalation-Caplain 01.pdf(1.1 MB)
When to stop dose escalation – MTD or MLD or ?
Session II: Implications of the new EU-Directive on clinical trials
A. Patat, Paris
EU-Directive-France-Patat.pdf(210 kB)
France
R. Frey, Wuppertal
EU-Directive-Germany-Frey.pdf(239 kB)
Germany
S. Warrington, London
EU-Directive-UK-Warrington 01.pdf(442 kB)
United Kingdom
J. van Gerven, Leiden
EU-Directive-Netherlands-van-Gerven.pdf(0.9 MB)
The Netherlands
C. Reh, Berlin
EU-Directive-Central-Europe-Reh.pdf(309 kB)
Central Europe
A. Patat, Paris
Comparisons-between-European-countries-Patat.pdf(438 kB)
Comparison between European countries
Session III: Safety issues in Phase I studies
M. Sibille, Lyon
Is-Phase-I-safe-Sibille 01.pdf(228 kB)
Is Phase I safe?
B. Reigner, Basel
First-dose-and-escalation-Reigner 01.pdf(121 kB)
First dose and dose escalation
G. Sanderink, Paris
Allometric scaling
No presentation available
Session IV: New tools in early drug development
E. Fuseau, Aix-en-Provence
PKPD-in-early-development-Fuseau 01.pdf(478 kB)
When and how does PK/PD modelling and simulation make sense in early development
K.L. Rost, Berlin
Informed consent process in pharmacogenomic studies (Germany, France, international view)
No presentation available
R. Myers, London
PET-scan-Myers 01.pdf(3.9 MB)
Imaging in early drug development
B. Acres, Strasbourg
New compounds derived from research on proteomics
No presentation available
Workshops
H. Allain, Rennes
Pharmacogenomics-and-drug-safety-Allain 01.pdf(385 kB)
Pharmacogenomics and drug safety
P. Maisonblanche, Paris
QTc-Maisonblanche 01.pdf(3.2 MB)
QTc: Predictability, Science, Regulation
M. Buyse, Bruxelles
Phase-I-in-oncology-Buyse 01.pdf(878 kB)
Phase I in Oncology