Final published version
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Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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TY - JOUR
T1 - Optimal Designs for Non-Compartmental Analysis of Pharmacokinetic Studies
AU - Barnett, Helen Yvette
AU - Geys, Helena
AU - Jacobs, Tom
AU - Jaki, Thomas Friedrich
PY - 2018
Y1 - 2018
N2 - In traditional toxicology trials, pharmacokinetics (PK) is investigated in the satellite group of animals, and the pharmacodynamics (PD) is investigated in the study group of animals. The new blood sampling method of microsampling opens up the opportunity to investigate both PK and PD in the same animals. To avoid excessive burden on the animals from the required blood sampling, sparse sampling schemes are typically utilized. Motivated by this application, this paper introduces a procedure to choose an optimal sparse sampling scheme and sampling time points using non-compartmental methods but which can be applied to further settings beyond this. We discuss how robust designs can be obtained and we apply and evaluate the approach to a range of scenarios to give an example of how it may be implemented. The results are compared to optimal designs for model based PK.
AB - In traditional toxicology trials, pharmacokinetics (PK) is investigated in the satellite group of animals, and the pharmacodynamics (PD) is investigated in the study group of animals. The new blood sampling method of microsampling opens up the opportunity to investigate both PK and PD in the same animals. To avoid excessive burden on the animals from the required blood sampling, sparse sampling schemes are typically utilized. Motivated by this application, this paper introduces a procedure to choose an optimal sparse sampling scheme and sampling time points using non-compartmental methods but which can be applied to further settings beyond this. We discuss how robust designs can be obtained and we apply and evaluate the approach to a range of scenarios to give an example of how it may be implemented. The results are compared to optimal designs for model based PK.
KW - Microsampling
KW - Minimax
KW - Sparse Sampling
KW - Optimal Designs
KW - Pharmacokinetic (PK) Sampling
KW - Non-compartmental Analysis
U2 - 10.1080/19466315.2018.1458647
DO - 10.1080/19466315.2018.1458647
M3 - Journal article
VL - 10
SP - 255
EP - 263
JO - Statistics in Biopharmaceutical Research
JF - Statistics in Biopharmaceutical Research
SN - 1946-6315
IS - 4
ER -