Pediatric Dosing Going Beyond Milligrams per Kilogram

30 04 2013

AAPS Blog

Andrew PorterfieldAndrew Porterfield has a master’s degree in biotechnology management from the University of Maryland and has worked as a marketing communications consultant for many biotechnology and pharmaceutical firms.

It was an unprecedented move: U.S. Health and Human Services Secretary Kathleen Sibelius overruled the FDA when she announced that Teva Pharmaceutical’s Plan B One Step contraceptive pill would not be available to women under 17 years of age. While many observers accused Sibelius of political motivations, the action underscored a far deeper problem for the pharmaceutical industry—how to develop safe and effective therapies for children.

Sibelius claimed that Teva’s study did not adequately address effects on girls as young as 11 (Teva’s study included three 11-year-olds, 35 children who were 14 years old, and 100 who were 15). Three people might be enough of a cohort in an adult trial, but probably wouldn’t address the wide variety of childhood development…

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