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Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.

Publication ,  Journal Article
Le, J; Poindexter, B; Sullivan, JE; Laughon, M; Delmore, P; Blackford, M; Yogev, R; James, LP; Melloni, C; Harper, B; Mitchell, J ...
Published in: Ther Drug Monit
February 2018

BACKGROUND: Dried blood spot (DBS) is a practical sampling strategy for pharmacokinetic studies in neonates. The utility of DBS to determine the population pharmacokinetics (pop-PK) of ampicillin, as well as accuracy versus plasma samples, was evaluated. METHODS: An open-label, multicenter, opportunistic, prospective study was conducted in neonates. Ampicillin concentrations from plasma and DBS (CONCPlasma and CONCDBS) were measured by liquid chromatographic tandem mass spectrometry and analyzed using pop-PK and statistical (including transformation) approaches. RESULTS: A total of 29 paired plasma and DBS samples from 18 neonates were analyzed. The median (range) gestational age and postnatal age were 37 (27-41) weeks and 8 (1-26) days, respectively. The geometric mean of CONCDBS to CONCPlasma ratio was 0.56. Correlation analysis demonstrated strong association between CONCPlasma and CONCDBS (r = 0.902, analysis of variance P < 0.001). Using linear regression transformation, the estimated CONCPlasma (eCONCPlasma) was derived using (CONCDBS - 3.223)/0.51. The median bias and geometric mean ratio improved to -11% and 0.88 (Wilcoxon signed-rank test, P < 0.001), respectively, when comparing eCONCPlasma to CONCPlasma. Furthermore, using pop-PK modeling, the median bias (interquartile range) for clearance and individual predicted concentrations improved to 8% (-11 to 50) and -8% (-34 to 11), respectively, when eCONCPlasma was used. CONCLUSIONS: After transformation, DBS sampling accurately predicted ampicillin exposure in neonates.

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Published In

Ther Drug Monit

DOI

EISSN

1536-3694

Publication Date

February 2018

Volume

40

Issue

1

Start / End Page

103 / 108

Location

United States

Related Subject Headings

  • Tandem Mass Spectrometry
  • Prospective Studies
  • Pharmacology & Pharmacy
  • Models, Biological
  • Male
  • Infant, Newborn
  • Humans
  • Female
  • Dried Blood Spot Testing
  • Chromatography, Liquid
 

Citation

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Le, J., Poindexter, B., Sullivan, J. E., Laughon, M., Delmore, P., Blackford, M., … Cohen-Wolkowiez, M. (2018). Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates. Ther Drug Monit, 40(1), 103–108. https://doi.org/10.1097/FTD.0000000000000466
Le, Jennifer, Brenda Poindexter, Janice E. Sullivan, Matthew Laughon, Paula Delmore, Martha Blackford, Ram Yogev, et al. “Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.Ther Drug Monit 40, no. 1 (February 2018): 103–8. https://doi.org/10.1097/FTD.0000000000000466.
Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Blackford M, et al. Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates. Ther Drug Monit. 2018 Feb;40(1):103–8.
Le, Jennifer, et al. “Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.Ther Drug Monit, vol. 40, no. 1, Feb. 2018, pp. 103–08. Pubmed, doi:10.1097/FTD.0000000000000466.
Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Blackford M, Yogev R, James LP, Melloni C, Harper B, Mitchell J, Benjamin DK, Boakye-Agyeman F, Cohen-Wolkowiez M. Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates. Ther Drug Monit. 2018 Feb;40(1):103–108.

Published In

Ther Drug Monit

DOI

EISSN

1536-3694

Publication Date

February 2018

Volume

40

Issue

1

Start / End Page

103 / 108

Location

United States

Related Subject Headings

  • Tandem Mass Spectrometry
  • Prospective Studies
  • Pharmacology & Pharmacy
  • Models, Biological
  • Male
  • Infant, Newborn
  • Humans
  • Female
  • Dried Blood Spot Testing
  • Chromatography, Liquid