Imperial College London
Alternate

Dr Lionel Tan

Faculty of Medicine, Department of Infectious Disease

Honorary Clinical Senior Lecturer
 
 
 
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Contact

 

+44 (0)20 3313 2065lionel.tan

 
 
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Location

 

Commonwealth BuildingHammersmith Campus

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Summary

 

Publications

Citation

BibTex format

@article{Bachhav:2023:10.1111/bcp.15554,
author = {Bachhav, SS and Taylor, M and Martin, A and Green, JA and Duparc, S and Rolfe, K and Sharma, H and Tan, LK and Goyal, N},
doi = {10.1111/bcp.15554},
journal = {Br J Clin Pharmacol},
pages = {1187--1197},
title = {A pharmacometrics approach to assess the feasibility of capillary microsampling to replace venous sampling in clinical studies: Tafenoquine case study.},
url = {http://dx.doi.org/10.1111/bcp.15554},
volume = {89},
year = {2023}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - AIM: Microsampling has the advantage of smaller blood sampling volume and suitability in vulnerable populations compared to venous sampling in clinical pharmacokinetics studies. Current regulatory guidance requires correlative studies to enable microsampling as a technique. A post hoc population pharmacokinetic (POPPK) approach was utilized to investigate blood capillary microsampling as an alternative to venous sampling. METHODS: Pharmacokinetic data from microsampling and venous sampling techniques during a paediatric study evaluating tafenoquine, a single-dose antimalarial for P. vivax, were used. Separate POPPK models were developed and validated based on goodness of fit and visual predictive checks, with pharmacokinetic data obtained via each sampling technique. RESULTS: Each POPPK model adequately described tafenoquine pharmacokinetics using a two-compartment model with body weight based on allometric scaling of clearance and volume of distribution. Tafenoquine pharmacokinetic parameter estimates including clearance (3.4 vs 3.7 L/h) were comparable across models with slightly higher interindividual variability (38.3% vs 27%) in capillary microsampling-based data. A bioavailability/bioequivalence comparison demonstrated that the point estimate (90% CI) of capillary microsample versus venous sample model-based individual post hoc estimates for area under the concentration-time curve from time zero to infinity (AUC0-inf ) (100.7%, 98.0-103.5%) and Cmax (79.7%, 76.9-82.5%) met the 80-125% and 70-143% criteria, respectively. Overall, both POPPK models led to the same dose regimen recommendations across weight bins based on achieving target AUC. CONCLUSIONS: This analysis demonstrated that a POPPK approach can be employed to assess the performance of alternative pharmacokinetic sampling techniques. This approach provides a robust solution in scenarios where variability in pharmacokinetic data collected via venous sampling and microsampling may not result in a s
AU  - Bachhav,SS
AU  - Taylor,M
AU  - Martin,A
AU  - Green,JA
AU  - Duparc,S
AU  - Rolfe,K
AU  - Sharma,H
AU  - Tan,LK
AU  - Goyal,N
DO  - 10.1111/bcp.15554
EP  - 1197
PY  - 2023///
SP  - 1187
TI  - A pharmacometrics approach to assess the feasibility of capillary microsampling to replace venous sampling in clinical studies: Tafenoquine case study.
T2  - Br J Clin Pharmacol
UR  - http://dx.doi.org/10.1111/bcp.15554
UR  - https://www.ncbi.nlm.nih.gov/pubmed/36199201
VL  - 89
ER  -
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