Briefing Information for the May 11, 2011 Meeting of the Pediatric Ethics Subcommittee, FDA Pediatric Advisory Committee
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Letter to Subcommittee from Robert M. Nelson, M.D., Ph.D., Senior Pediatric Ethicist/Lead Medical Officer Office of Pediatric Therapeutics(PDF - 39KB)
- FDA Guidance Document on Exploratory IND Studies (PDF - 220KB)
Consultation on a Pediatric Protocol, March 11, 2011(PDF - 50KB) Drug Discovery Today: Challenges for Drug Studies in Children: CYP3A Phenotyping as Example Therapeutic Drug Monitoring: A High-Throughput Assay Using Liquid Chromatography-Tandem Mass Spectrometry for Simultaneous in vivo Phenotyping of 5 Major Cytochrome p450 Enzymes in Patients Clinical Pharmacology and Therapeutics: Reduced Activities of Cytochrome P450 1A2 and Xanthine Oxidase in Children With Growth Hormone Deficiency Clinical Pharmacology and Therapeutics: Use of Microdosing to Predict Pharmacokinetics at the Therapeutic Dose: Experience With 5 Drugs Ethical Considerations in Conducting Pediatric Research(PDF - 387KB) Cancer Chemotherapy and Pharmacology: Phase 0 Clinical Trials in Oncology: A Paradigm Shift for Early Drug Development?