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One Year Post-Exclusivity Adverse Event Review: Oxcarbazepine Pediatric Advisory Committee Meeting November 16, 200

One Year Post-Exclusivity Adverse Event Review: Oxcarbazepine Pediatric Advisory Committee Meeting November 16, 200

One Year Post-Exclusivity Adverse Event Review: Oxcarbazepine Pediatric Advisory Committee Meeting November 16, 2006. Felicia L. Collins, MD, MPH, FAAP Medical Officer Pediatric and Maternal Health Staff Office of New Drugs Center for Drug Evaluation and Research

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852 views • 51 slides
Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs

Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs

Re-Examination of the Design of Early Clinical Trials for Molecularly Targeted Drugs. Richard Simon, D.Sc. National Cancer Institute linus.nci.nih.gov/brb. Objectives of Phase I Trials. Develop dose/schedule Determine whether the drug inhibits the targeted pathway. Dose/Schedule.

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467 views • 32 slides
OPTIMUS

OPTIMUS

OPTIMUS. Randomized Comparison of a High Clopidogrel Maintenance Dose in Patients with Diabetes Mellitus and Coronary Artery Disease: Results of the Optimizing Antiplatelet Therapy in Diabetes Mellitus (OPTIMUS) Study.

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365 views • 11 slides
EXCELLENT Trial

EXCELLENT Trial

EXCELLENT Trial. The Randomized Comparison of Six-Month versus 12-Month Duration of Dual Antiplatelet Therapy after Implantation of DES: From A Comparison of EES versus SES for Coronary Revascularization (EXCELLENT) Trial. Study Design Randomized Prospective Open -label Noninferiority.

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300 views • 2 slides

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