Addressing the Barriers to Pediatric Drug Development Workshop Summary (2008) / Chapter Skim
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1 Introduction
1 Introduction
Pages 7-9
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Response to Drugs in Various Age Groups Differences between children and adults in the metabolism, renal clearance, other drug disposition mechanisms, and overall response to medications are due to profound anatomical, physiological, and developmental differences (Kearns et al., 2003; McKinney, 2003)
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From page 8... ...
While such use can be beneficial to the patient, it can also result in adverse reactions due to a lack of understanding of the drug's pharmacokinetics in this population. Current laws employ both incentives and mandates to encourage drug makers to test their products in pediatric populations and to enhance the pediatric information provided on drug labels.
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From page 9... ...
Chapter 3 addresses challenges to the development of drugs for children, including the barriers posed by ethical concerns, economic obstacles, and logistical and technical issues; the difficulty of devising appropriate formulations; and issues of dosing, bioavailability, and drug response. Chapter 4 considers the potential adaptation of existing models -- such as vaccine development, European regulatory models, and the approach used by St.
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