Protocol Deviation in Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care - Doxycycline
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https://dash.nichd.nih.gov/dataset/19032
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资源简介：
Protocol Deviation data
Study Description
Aim: Characterize the PK of doxycycline administered to children per standard of care as prescribed by their treating caregiver.
Methods: The PK and safety analyses was conducted for doxycycline data from NICHD-2011-POP01, a multicenter, prospective opportunistic PK study of understudied drugs in children less than 21 years of age who receive drugs per standard of care, as prescribed by a treating caregiver. The NICHD-2011-POP01 study enrolls participants under multiple drugs of interest (DOI) including doxycycline, and is actively enrolling participants.
Results: A one-compartment model offered the best fit to characterize doxycycline PK data based on model selection criteria. No AEs or SAEs related to study procedures were reported. Children less than 21 years of age who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver who are able to consent/assent and are not pregnant
创建时间：
2018-09-11
