Evaluation of Publication of Pediatric Drug Trials
Sign Up to like & getrecommendations! Published in 2021 at "JAMA Network Open"
DOI: 10.1001/jamanetworkopen.2021.5829
Abstract: This cross-sectional study assesses the rate of publication of pediatric drug trials and examines the information lost when trials are not published. read more here.
Keywords: pediatric drug; evaluation publication; drug trials; publication pediatric ... See more keywords
Pediatric drug information available at the time of new drug approvals: A cross‐sectional analysis
Sign Up to like & getrecommendations! Published in 2018 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4351
Abstract: Greater than 50% of drugs lack pediatric labeling information, resulting in widespread “off‐label” use in children. To increase pediatric prescribing information, the Pediatric Research Equity Act (PREA) was passed in 2003, requiring new drug applications… read more here.
Keywords: information; drug information; information available; new drug ... See more keywords
Masking by vaccines in pediatric drug safety signal detection in the EudraVigilance database
Sign Up to like & getrecommendations! Published in 2018 at "Pharmacoepidemiology and Drug Safety"
DOI: 10.1002/pds.4623
Abstract: Postmarketing drug safety surveillance relies upon measures of disproportionate reporting in spontaneous reporting systems. It has been hypothesized that products or events reported frequently may “mask” signals. read more here.
Keywords: masking vaccines; drug; drug safety; vaccines pediatric ... See more keywords
State-of-the-Art Review on Physiologically Based Pharmacokinetic Modeling in Pediatric Drug Development
Sign Up to like & getrecommendations! Published in 2018 at "Clinical Pharmacokinetics"
DOI: 10.1007/s40262-018-0677-y
Abstract: Physiologically based pharmacokinetic modeling and simulation is an important tool for predicting the pharmacokinetics, pharmacodynamics, and safety of drugs in pediatrics. Physiologically based pharmacokinetic modeling is applied in pediatric drug development for first-time-in-pediatric dose selection,… read more here.
Keywords: pharmacokinetic modeling; drug development; based pharmacokinetic; physiologically based ... See more keywords
Recent Use of Pediatric Extrapolation in Pediatric Drug Development in US.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of biopharmaceutical statistics"
DOI: 10.1080/10543406.2023.2170407
Abstract: The regulatory standards of the United States Food and Drug Administration (FDA) require substantial evidence of effectiveness from adequate and well-controlled trials, for drugs developed in both adults and children. However, when scientifically justified, relying… read more here.
Keywords: pediatric drug; extrapolation; labeling changes; drug development ... See more keywords
Clinician preferences for neurotechnologies in pediatric drug‐resistant epilepsy: A discrete choice experiment
Sign Up to like & getrecommendations! Published in 2022 at "Epilepsia"
DOI: 10.1111/epi.17328
Abstract: Novel and minimally invasive neurotechnologies offer the potential to reduce the burden of epilepsy while avoiding the risks of conventional resective surgery. Few neurotechnologies have been tested in randomized controlled trials with pediatric populations, leaving… read more here.
Keywords: pediatric drug; drug resistant; clinician preferences; epilepsy ... See more keywords
Physiologically Based Pharmacokinetic Models Are Effective Support for Pediatric Drug Development
Sign Up to like & getrecommendations! Published in 2021 at "AAPS PharmSciTech"
DOI: 10.1208/s12249-021-02076-w
Abstract: Pediatric drug development faces many difficulties. Traditionally, pediatric drug doses are simply calculated linearly based on the body weight, age, and body surface area of adults. Due to the ontogeny of children, this simple linear… read more here.
Keywords: drug development; drug; model; pbpk model ... See more keywords