Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Status:
Completed
Trial end date:
2019-11-01
Target enrollment:
Participant gender:
Summary
Understudied drugs will be administered to children per standard of care as prescribed by
their treating caregiver and only biological sample collection during the time of drug
administration will be involved. A total of approximately 7000 children aged <21 years who
are receiving these drugs for standard of care will be enrolled and will be followed for up a
maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of
understudied drugs for which specific dosing recommendations and safety data are lacking. The
prescribing of drugs to children will not be part of this protocol. Taking advantage of
procedures done as part of routine medical care (i.e. blood draws) this study will serve as a
tool to better understand drug exposure in children receiving these drugs per standard of
care. The data collected through this initiative will also provide valuable pharmacokinetic
and dosing information of drugs in different pediatric age groups as well as special
pediatric populations (i.e. obese).
Details
Lead Sponsor:
Daniel Benjamin
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) OpAns, LLC The Emmes Company, LLC The EMMES Corporation