Use of Clinical Trial Simulations to Compare the Performance of Different Approaches for Population Analyses of Pediatric Pharmacokinetic Data.
Sign Up to like & getrecommendations! Published in 2023 at "Journal of clinical pharmacology"
DOI: 10.1002/jcph.2236
Abstract: Adequate characterization of the pharmacokinetics of a drug in pediatrics is mainstay to pediatric development programs and is critical for accurate dose selection in pediatrics. Analysis approaches can impact estimation and characterization of pediatric pharmacokinetic… read more here.
Keywords: parameters using; adult; pediatric data; clinical trial ... See more keywords
Pharmacokinetic evaluation of vigabatrin dose for the treatment of refractory focal seizures in children using adult and pediatric data
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DOI: 10.1016/j.eplepsyres.2019.01.002
Abstract: Vigabatrin is indicated as adjunctive therapy for refractory focal seizures. For children, European recommendations indicate maintenance doses varying from 30 to 100 mg/kg/day for this indication. Since cumulated dose was associated with retinal toxicity, it is… read more here.
Keywords: adult; seizures children; focal seizures; refractory focal ... See more keywords
Sharing and Safeguarding Pediatric Data
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DOI: 10.3389/fgene.2022.872586
Abstract: Data sharing is key to advancing our understanding of human health and well-being. While issues related to pediatric research warrant strong ethical protections, overly protectionist policies may serve to exclude minors from data sharing initiatives.… read more here.
Keywords: data sharing; pediatric data; safeguarding pediatric; pediatric research ... See more keywords
External Evaluation of Risperidone Population Pharmacokinetic Models Using Opportunistic Pediatric Data
Sign Up to like & getrecommendations! Published in 2022 at "Frontiers in Pharmacology"
DOI: 10.3389/fphar.2022.817276
Abstract: Risperidone is approved to treat schizophrenia in adolescents and autistic disorder and bipolar mania in children and adolescents. It is also used off-label in younger children for various psychiatric disorders. Several population pharmacokinetic models of… read more here.
Keywords: pediatric data; population pharmacokinetic; risperidone population; risperidone ... See more keywords