Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval Kanecia Zimmerman,

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Exposure Matching of Pediatric Anti-infective Drugs: Review of Drugs Submitted to the Food and Drug Administration for Pediatric Approval Kanecia Zimmerman, MD, MPH, Martin Putera, MD, Christoph P. Hornik, MD, MPH, P. Brian Smith, MD, MPH, MHS, Daniel K. Benjamin, MD, PhD, MPH, Yeruk Mulugeta, PharmD, Gilbert J. Burckart, PharmD, Michael Cohen-Wolkowiez, MD, PhD, Daniel Gonzalez, PharmD, PhD Clinical Therapeutics Volume 38, Issue 9, Pages 1995-2005 (September 2016) DOI: 10.1016/j.clinthera.2016.06.003 Copyright © 2016 Terms and Conditions

Figure 1 Flow chart of drug inclusion in the final analysis. PK = pharmacokinetic. Clinical Therapeutics 2016 38, 1995-2005DOI: (10.1016/j.clinthera.2016.06.003) Copyright © 2016 Terms and Conditions

Figure 2 Comparison of pediatric with adult area under the concentration-time curve without outliers: age (A) <30 days, (B) 1 month to <2 years, (C) 2 to 11 years, and (D) 12 to 16 years. Drug products were considered outliers and excluded from the figure if the range of ratios for the drug product was >2.5 SD of the range of ratios for the age group of interest. Multiple studies for a single drug will have the same identifying number (eg, 3 studies supporting the 2- to 11-year-old age group for a drug will be located on the x-axis at 7.0, 7.4, and 7.8). Blue dots represent the AUCchild/AUCadult median (or mean) ratio. The solid black line represents the equivalence median (or mean) AUC between children and adults (ratio = 1). Horizontal dashed lines represent the upper and lower bounds of a normalized adult AUC range. Ratios and ranges that fall within the dashed lines indicate pediatric AUC values within the adult range. Clinical Therapeutics 2016 38, 1995-2005DOI: (10.1016/j.clinthera.2016.06.003) Copyright © 2016 Terms and Conditions