ReviewClinical pharmacokinetics1994
Paediatric labelling requirements. Implications for pharmacokinetic studies.
Review in Clinical pharmacokinetics, 1994. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed.
- Population pharmacokinetics of pyrimethamine and sulfadoxine in children treated for congenital toxoplasmosis.Antimicrobial agents and chemotherapy · 2004Trial
- Off-Label Use of Medicines in Pediatrics: Necessary and Not "Off-Knowledge".The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2026Article
- Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities.Paediatric drugs · 2008Article
- Pain management in the critically ill child.Indian journal of pediatrics · 2001Review
- Bayesian forecasting in paediatric populations.Clinical pharmacokinetics · 1996Review
- The introduction of new drugs into anaesthetic practice: a perspective in pharmaceutical development and regulation.Canadian journal of anaesthesia = Journal canadien d'anesthesie · 1995Review
- Ceftibuten in paediatrics.Clinical pharmacokinetics · 1994Article
- Pharmacokinetics of anti-infective agents in paediatric patients.Clinical pharmacokinetics · 1994Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The US Food and Drug Administration (FDA) has proposed new labelling regulations that describe alternative approaches for providing additional information to support labelling a drug, already approved for use in adults, for use in children. Therefore, the study of drugs in paediatric populations may now be encouraged. Paediatric pharmacokinetic studies are an important part of these trials. This action by the FDA may help resolve the ethical and technological concerns about the performance of clinical trials in children, and may render paediatric clinical trials more feasible. Most investigations in children are opportunistic in nature and their design is often constrained by a requisite noninvasive approach. Appropriately applied population-based techniques for both pharmacokinetic and pharmacodynamic data analysis may represent the most robust approach for generating a sufficiently large and accurate database for the use of new or old drugs in paediatric patients. Accordingly, this information, which is crucial for paediatric labelling of any drug product, must be obtained in infants and children if we are to truly individualize therapy for paediatric patients. The funding of 6 Pediatric Pharmacology Research Units by the US National Institutes of Health, and guidelines for application of pharmacokinetic methods to children may further contribute to the performance of paediatric clinical trials.
Indexed as
Identifiers
8013163What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.