The Integration of Allometry and Virtual Populations to Predict Clearance and Clearance Variability in Pediatric Populations over the Age of 6 Years

Author:

Edginton Andrea N.,Shah Bhavank,Sevestre Michael,Momper Jeremiah D.

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Reference27 articles.

1. Wang Y, Jadhav PR, Lala M, Gobburu JV. Clarification on precision criteria to derive sample size when designing pediatric pharmacokinetic studies. J Clin Pharmacol. 2012;52:1601–6.

2. US FDA. Medical, statistical, and clinical pharmacology reviews of pediatric studies conducted under Section 505A and 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049872.htm . Accessed 1 Sept 2012.

3. US FDA. Summaries of medical and clinical pharmacology reviews—summaries of medical and clinical pharmacology reviews as of 15 Jan 2008. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm161894.htm . Accessed 1 Sept 2012.

4. Third National Health and Nutrition Examination Survey, (NHANES III). 1997. National Center for Health Statistics Hyattsville, MD 20782. http://www.cdc.gov/nchs/nhanes.htm .

5. Willmann S, Hohn K, Edginton A, Sevestre M, Solodenko J, Weiss W, et al. Development of a physiology-based whole-body population model for assessing the influence of individual variability on the pharmacokinetics of drugs. J Pharmacokinet Pharmacodyn. 2007;34:401–31.

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