Session Information
2006 Midyear Clinical Meeting
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Clinical Trials in Pediatrics: The Basis for Therapeutic Controversy?
Track:
Sessions
Program Code: 225-L01
Date: Tuesday, December 5, 2006
Time: 8:00 AM to 11:00 AM
MODERATOR:
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SPEAKER(S):
Loyd V. Allen, Jr., Ph.D., R.Ph., Editor-in-Chief, International Journal of Pharmaceutical Compounding, Edmond, OK
Pediatric Formulations: A Compounding Dilemma
George P. Giacoia, M.D., Program Scientist, Pediatric Pharmacology Research Unit Network, National Institute of Child Health & Human Development, National Institutes of Health, Bethesda, MD
Issues in Pediatric Therapeutics
Richard D. Leff, Pharm.D., Regional Dean and Professor, Texas Tech University Health Sciences Center, School of Pharmacy, Dallas
Are Pediatric Formulations Altering Clinical Trial Outcomes?
Putting It All Together and Taking Steps Forward
Description
Learning Objectives: Describe the impact of the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act on drug therapy research in children. Explain the scope of the problem related to the limited number of commercially available pediatric formulations. List the steps in the process required for performing reliable and valid stability trials on compounded formulations. Explain the impact of the lack of formulation information in pediatric trials on our ability to interpret and apply their results into practice. Describe how to develop strategies for pharmacists to overcome the barriers in drug formulation knowledge to provide drug therapy to their patients.