Resampling methods in sparse sampling situations in preclinical pharmacokinetic studies

Journal of Pharmaceutical Sciences
H Mager, G Göller

Abstract

Toxicokinetic studies often require destructive sampling and the determination of drug concentrations in the various organs. Classically, the corresponding information is summarized in one mean concentration-time profile, which is regarded as representative for the animal population. On the basis of a mean profile, only estimates of the secondary pharmacokinetic parameters (for example AUC, t1/2) but no variability measures may be obtained. In this paper two resampling techniques are contrasted to Bailer's approach. The results obtained show that the resampling techniques can be considered a reliable alternative to Bailer's approach for the estimation of the standard error of the AUC t(k)0 in the case of normally distributed concentration data. They can be extended to the estimation of a variety of other secondary pharmacokinetic parameters and their respective standard deviations. One disadvantage with Bailer's method is its restriction to linear functions of the concentrations. On the other hand, using the population approach, prior knowledge of the underlying pharmacokinetic model is necessary. The resampling techniques discussed here, the "pseudoprofile-based bootstrap" (PpbB) and the "pooled data bootstrap" (PDB), are nonc...Continue Reading

References

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Citations

Jan 15, 2011·Pharmaceutical Research·Jeremy D ScheffIoannis P Androulakis
Feb 18, 1999·Toxicology Letters·I Horii
Apr 23, 2008·Journal of Cardiovascular Pharmacology·Yelena SelektorKarl T Weber
May 8, 2009·Journal of Pharmaceutical Sciences·Yi ZhangQingcheng Mao
Sep 7, 2007·Journal of Veterinary Pharmacology and Therapeutics·K A CortrightA L Craigmill
Oct 21, 2006·Biochemical and Biophysical Research Communications·Yusuke AdachiHiromu Sakurai
Jan 16, 2007·Drug Metabolism and Pharmacokinetics·Seiji TakemotoYoshinobu Takakura
Apr 3, 2004·Brazilian Journal of Medical and Biological Research = Revista Brasileira De Pesquisas Médicas E Biológicas·E A NunanT Moraes-Santos
May 18, 2011·Metallomics : Integrated Biometal Science·Yutaka YoshikawaHiroyuki Yasui
Jul 18, 2018·Molecular Pharmacology·Nora LeeJoanne Wang
Nov 22, 2017·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Michael Z LiaoQingcheng Mao
Jun 6, 2014·The Journal of Pharmacology and Experimental Therapeutics·Diana L ShusterQingcheng Mao
Feb 14, 2003·Drug Metabolism and Disposition : the Biological Fate of Chemicals·Frédéric ImbertFrançois Gimenez
Mar 22, 2016·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Mackenzie L CottrellAngela D M Kashuba
Aug 15, 2017·Biomaterials·Emily A KrogstadKim A Woodrow
Sep 22, 2021·ACS Infectious Diseases·Mercedes Gonzalez-JuarreroBernd Meibohm

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