ArticleJournal of pharmacokinetics and pharmacodynamics2007
Establishing bioequivalence in serial sacrifice designs.
Article in Journal of pharmacokinetics and pharmacodynamics, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
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Who cites it
5 citing papers in PubMed.
- Effectiveness of Thoracic Wall Blocks in Video-Assisted Thoracoscopic Surgery, a Network Meta-Analysis.Journal of pain research · 2023Article
- The dynamics of the early inflammatory response in double-hit burn and sepsis animal models.Cytokine · 2011Article
- Comparison of the cytokine and chemokine dynamics of the early inflammatory response in models of burn injury and infection.Cytokine · 2011Article
- Assessment of pharmacologic area under the curve when baselines are variable.Pharmaceutical research · 2011Article
- Non-compartmental estimation of pharmacokinetic parameters in serial sampling designs.Journal of pharmacokinetics and pharmacodynamics · 2009Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Nonclinical in vivo animal studies have to be completed before starting clinical studies of the pharmacokinetic behavior of a drug in human subjects. The classic complete data design, where each animal is sampled for analysis once per time point, is usually only applicable for large animals using the traditional two-stage approach. The first stage involves estimation of pharmacokinetic parameters for each animal separately and the second stage uses the individual parameter estimates for statistical inference. In the case of rats and mice, where blood sampling is restricted, the batch design or the serial sacrifice design may be applicable. In batch designs samples are taken more than once from each animal, but not at all time points. In serial sacrifice designs only one sample is taken from each animal. In this paper, three methods are presented to construct confidence intervals for the ratio of two AUCs assessed in a serial sacrifice design, which can be used to assess bioequivalence in this parameter. The presented methods are compared in a simulation study.
Indexed as
Identifiers
17053981What 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.