'Concomitant medications' diaporamas de présentation

Reinhard Baildon, M.D.

Reinhard Baildon, M.D. Executive Director Clinical Development Pfizer Global Research & Development. Voriconazole. Introduction In vitro and in vivo Data Clinical Pharmacology Efficacy Safety Conclusion. Voriconazole Development Program. First in human: 1991

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Vaccinations: Myths vs. Facts

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Vaccinations: Myths vs. Facts

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Aliskiren Combined with Losartan in Type 2 Diabetes and Nephropathy

Aliskiren Combined with Losartan in Type 2 Diabetes and Nephropathy. N Engl J Med 2008;358:2433-46.

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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, 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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Prescribing Information can be found on the last page

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H5N1 Pediatric Experience

H5N1 Pediatric Experience. A Randomized, Double-blinded, Placebo-controlled, Phase I/II, Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine In Healthy Children Aged 2 Years Through 9 Years (DMID 04-077)

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Labeling as a route map for drug development Mike Page Senior Director, Regulatory Affairs

27 March 2009. Labeling as a route map for drug development Mike Page Senior Director, Regulatory Affairs. Definitions . What is labeling? Why use the label as the guide? When to start? How to manage label development? Some examples. PLEASE ASK QUESTIONS. What is labeling?.

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Psychiatric Adverse Events with Drug Treatments of ADHD

Psychiatric Adverse Events with Drug Treatments of ADHD. Review of Postmarketing Safety Data: Pediatric Population Kate Gelperin, M.D., M.P.H. FDA Office of Drug Safety Division of Drug Risk Evaluation. Points for discussion today:. Methods for case review and analysis

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Pharmacogenetics of Tamoxifen An FDA Perspective

Pharmacogenetics of Tamoxifen An FDA Perspective. Clinical Pharmacology Subcommittee October 18, 2006 Rockville, Maryland. NAM Atiqur Rahman, Ph.D. Director Division of Clinical Pharmacology 5 Office of Clinical Pharmacology Office of Translational Sciences CDER, FDA.

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639 views • 33 slides

One Year Post-Exclusivity Adverse Event Review: Ondansetron Pediatric Advisory Committee Meeting November 16, 2006

One Year Post-Exclusivity Adverse Event Review: Ondansetron 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 Food and Drug Administration.

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Warfarin

517 views • 24 slides

Neonatal Adverse Events Associated with in utero SSRI/SNRI Exposure

Neonatal Adverse Events Associated with in utero SSRI/SNRI Exposure. Robert Levin, M.D. Medical Reviewer DNDP FDA. SSRIs and SNRI. Selective Serotonin Reuptake Inhibitors: fluoxetine, sertraline, paroxetine, paroxetine CR, fluvoxamine, citalopram

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The Challenges of Clinical Trial Design in Evaluating HIV Antiretroviral Use in Heavily Pre-Treated Patients

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When do I need an IND ?

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Pain Agitation & Delirium

Pain Agitation & Delirium. SCCM 2013. Pain assessment. i . We recommend that pain be routinely monitored in all adult ICU patients (+1B).

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Invasive versus conservative treatment in unstable coronary syndromes (ICTUS) Trial

ICTUS Trial. Invasive versus conservative treatment in unstable coronary syndromes (ICTUS) Trial. Presented at The European Society of Cardiology Scientific Congress 2006 Presented by RJ De Winter. ICTUS Trial: Background.

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Informed Consent

Informed Consent. Schizophrenia / Bipolar Studies Patient Consent Only: 98.5% Legal Representative Only: 0% Both Patient and Legal Representative 1.5% Dementia Study Patient Consent Only 49% Legal Representative Only 41% Both Patient and Legal Representative 10%. 4614.01.

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Tolerability and efficacy of Azelastine eye drops in the treatment of allergic conjunctivitis, large scale experience in

220 views • 1 slides