D._Austin_25.05.07.ppt

Human pharmacology for biologicals – First into man studies

CPI_AGAH_HC_042207.ppt

Tolerability and safety: Predictability of QT prolongation in healthy subjects from preclinical experiments

W._Cawello__2__25.05.07.pdf

Pharmacokinetics and bioavailability derived from various body fluids

Ph._Danjou_21.06.07.pdf

Imaging in Early Drug Development

F._Fliegert__30.05.07.pdf

Biomarkers in CNS drug development

Development_Of_Meaningful_Interaction_Studies_For_Combination_Therapies.pdf

Development of Meaningful Interaction Studies for Combination Therapies

J.Grevel_25.05.07.ppt

PK and PD as predictors of clinical effect

Ch._Schneider_BAPU_WS_31.05.07.pdf

Handling of First-in-man trials: regulatory rethink?

Ch._Schneider__2__WS_31.05.07.pdf

Current regulatory developments relevant to human

B._Schug_25.05.07.pdf

Need for a European Trial Data Base Introductory Remarks

H._Seyberth_26.05.07_WS_I.ppt

Workshop: Designs of human pharmacology trials for paediatric populations

M._Sibille_25.05.07_EarlySafety.pdf

Interpretation of early safety signals

M._Sibille_25.05.07_MTD_Oxford_debate.pdf

Is priority to MTD - maximal tolerated dose - the best way?

C._Steffen_FIM.ppt

Clinical Trial Authorisation in Germany for First-in-Man Trials with NCEs

D._Tremblay_26.05.07.ppt

New regulatory requirements for first into man studies in France