1. ONCOLOGY Drug Development 2. ONCOLOGY Drug development Identify Candidate Compounds Screening Preclinical Evaluation Production and Formulation Phase I, II, III, IV Clinical…

Slide 1SPIRIT IV A Prospective, Randomized Trial Comparing an Everolimus-Eluting Stent and a Paclitaxel-Eluting Stent in Patients with Coronary Artery Disease One Year Clinical…

Slide 1SORT-OUT III: A Prospective Randomized Comparison of Zotarolimus-Eluting and Sirolimus-Eluting Stents in Patients with Coronary Artery Disease Michael Maeng, Klaus…

Slide 1Emerging Issues with Adaptation of Clinical Trial Design in Drug Development* H.M. James Hung Division of Biometrics I, Office of Biostatistics, OPaSS, CDER, FDA Presented…

Slide 1Clinical Evaluation of Preventive Vaccines: Use of Bridging Studies Marion F. Gruber, Ph.D. 2006 FDA/Industry Statistics Workshop Washington D.C., September 29, 2006…

Slide 1Optimal Antifungal Prophylaxis The Case for Posaconazole Oliver A. Cornely, MD, FIDSA Dep. I for Internal Medicine Hematology - Oncology Infectious Diseases – Intensive…

Slide 1Introduction to Toxicology A Brief Introduction to the Concepts of Toxicology We Will Be Using Throughout This Course Slide 2 Units Used to Measure Chemicals in the…

Slide 1OPTIMIZE: A Prospective, Randomized Trial of 3 Months Versus 12 Months of Dual Antiplatelet Therapy with the Endeavor Zotarolimus-Eluting Stent Fausto Feres, MD, PhD…

Slide 1 Slide 2 Slide 3  Non-colon › Esophagogastric › Pancreatic › Hepatobiliary Slide 4 Slide 5  Phase III trial of everolimus in previously treated patients…

Slide 1Administration of Ticagrelor in the cath Lab or in the Ambulance for New ST elevation myocardial Infarction to open the Coronary artery G. Montalescot, COI are available…