Improving Pediatric Dosing Through Pediatric Initiatives: What We Have Learned

Rodríguez, William J.; Selen, Arzu; Avant, Debbie; Chaurasia, Chandra S.; Crescenzi, Terrie; Gieser, Gerlie; Giacinto, Jennifer Di; Huang, Shiew‐Mei; Lee, Peter; Mathis, Lisa L.; Murphy, Dianne; Murphy, Shirley; Roberts, Rosemary; Sachs, Hari Cheryl; Suárez, Sandra; Tandon, Veneeta; Uppoor, Ramana

doi:10.1542/peds.2007-1529

Cited by 145 publications

(101 citation statements)

References 5 publications

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“…A These changes have resulted in alterations in the labelling of over 100 medications, because the research identified heterogeneous pharmacokinetics and pharmacodynamics across the stages of child development when these drugs were specifically studied. 6 Similar strategies exist in the European Union where pharmaceutical companies that undertake pediatric research in orphan drugs are given an additional two years on marketing exclusivity. B However, in our study, all off-label drugs, except two, were non-proprietary.…”

Section: Discussionmentioning

confidence: 99%

“…4,5 When drugs are studied rigorously in children, it is clear that dosage regimes based on age, weight, and body surface area do not reflect actual pharmacokinetics of the drugs across the various stages of pediatric development. 6 Additionally, while a given drug may be effective in adult models of disease, in children, the optimal dose is often unknown, the efficacy is uncertain, the side effects are not established, and adverse outcomes are not described. Currently, before a drug is approved for pediatric use, rigorous studies in children (or in a pediatric sub-population, such as neonates) are required in order to devise a product monograph that specifies a clinical indication, a dosing schedule, and a formulation.…”

mentioning

confidence: 99%

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Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Doherty

Pascuet

et al. 2010

Can J Anesth/J Can Anesth

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Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Doherty

Pascuet

et al. 2010

Can J Anesth/J Can Anesth

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“…A review conducted by Rodriguez and co-workers reported that dosing changes were made for more than 20% of 108 drugs in response to the results from a required paediatric pharmacokinetic study. This highlights the limitations of extrapolation of adult dosages into paediatric populations [76].…”

Section: Paediatric Dose Selectionmentioning

confidence: 98%

Paediatric pharmacokinetics: key considerations

Batchelor

Marriott

2015

Brit J Clinical Pharma

243

163

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A number of anatomical and physiological factors determine the pharmacokinetic profile of a drug. Differences in physiology in paediatric populations compared with adults can influence the concentration of drug within the plasma or tissue. Healthcare professionals need to be aware of anatomical and physiological changes that affect pharmacokinetic profiles of drugs to understand consequences of dose adjustments in infants and children. Pharmacokinetic clinical trials in children are complicated owing to the limitations on blood sample volumes and perception of pain in children resulting from blood sampling. There are alternative sampling techniques that can minimize the invasive nature of such trials. Population based models can also limit the sampling required from each individual by increasing the overall sample size to generate robust pharmacokinetic data. This review details key considerations in the design and development of paediatric pharmacokinetic clinical trials.

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“…[1][2][3][4] Clinicians often treat children with offlabel and unlicensed medications that have been tested in and approved for adult populations without pediatricspecific guidelines, with as many as 78% of hospitalized children receiving medications lacking age-specific approval. 3,[5][6][7] The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), both of which were permanently reauthorized in May of 2012, seek to increase the study of drugs in children and address some of the concerns with the pediatric research infrastructure that have long been recognized.…”

Section: Discussionmentioning

confidence: 99%

Analysis of Pediatric Clinical Drug Trials for Neuropsychiatric Conditions

2013

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BACKGROUND AND OBJECTIVE: Neuropsychiatric conditions represent a large and increasing disease burden in children. A number of drugs are available for the treatment of these conditions, but most drugs have not been adequately tested in children, and off-label drug use remains widespread. We sought to define and quantify recent and ongoing clinical research on the use of neuropsychiatric drugs in children. METHODS: Drug trials registered in ClinicalTrials.gov between 2006 and 2011 and studying neuropsychiatric conditions were selected and classified based on the drug’s Food and Drug Administration (FDA) approval status in children. We measured the proportion of trials seeking to expand the use of a drug to pediatric patients and the proportion of available drugs studied in children. RESULTS: Only 10% of neuropsychiatric trials focused on children. Of 303 drugs studied in both pediatric and adult populations, 90% lacked FDA approval in children and 97% were not approved in children for the indication studied. However, only 19% of all neuropsychiatric drugs were under study in pediatric populations, with as few as 8% of either antidepressant or antipsychotic drugs. Overall, 76% of pediatric drug trials examined a drug previously unapproved in children and 26% explored the use of a drug for a new indication. CONCLUSIONS: Despite the rising prevalence of neuropsychiatric disease and the paucity of FDA-approved pediatric drugs, only a small proportion of trials focus on pediatric populations and these trials cover only a fraction of available drugs. This deficiency is most pronounced for depression and schizophrenia.

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Improving Pediatric Dosing Through Pediatric Initiatives: What We Have Learned

Cited by 145 publications

References 5 publications

Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Off-label drug use in pediatric anesthesia and intensive care according to official and pediatric reference formularies

Paediatric pharmacokinetics: key considerations

Analysis of Pediatric Clinical Drug Trials for Neuropsychiatric Conditions

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