The US FDA should at minimum require testosterone replacement therapies (TRT) sponsors to conduct pharmacokinetic (PK) studies under the Pediatric Research Equity Act (PREA) to inform dosing in children and comparisons between different formulations, members of the Pediatric Advisory Committee told the agency.
Testosterone Products Need Pediatric PK Studies At Minimum, US FDA Panel Says
Members of Pediatric Advisory Committee suggest that PK studies are essential to inform testosterone dosing in children and comparisons between different formulations.
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