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Pharmacokinetics of Off Label Pediatric Medications

Recruiting
1 - 8 years of age
Both
Phase N/A

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Overview

The purpose of this study is to measure the level of medicines found in body fluids such as blood, urine, spinal fluid of children.

Description

There is a lack of safety, pharmacokinetic and efficacy data of therapeutic agents in children and infants. Samples used for measurement will be from scavenged samples. i.e. any extra blood/body fluid samples from a test done as part of the standard of care.

Eligibility

Inclusion Criteria:

  • Children less than 8 years of age
  • Receiving a therapeutic agent at a dose or for an indication not currently included on the FDA label as part of standard of care

Exclusion Criteria:

  • Lack of consent

Study details

Off Label Use of Medications in Pediatric Patients

NCT01286519

University of North Carolina, Chapel Hill

26 May 2024

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