A Model-Informed Method for the Purpose of Precision Dosing of Isoniazid in Pulmonary Tuberculosis.
Journal
Clinical pharmacokinetics
ISSN: 1179-1926
Titre abrégé: Clin Pharmacokinet
Pays: Switzerland
ID NLM: 7606849
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
accepted:
28
11
2020
pubmed:
23
2
2021
medline:
29
10
2021
entrez:
22
2
2021
Statut:
ppublish
Résumé
This study aimed to develop and evaluate a population pharmacokinetic model and limited sampling strategy for isoniazid to be used in model-based therapeutic drug monitoring. A population pharmacokinetic model was developed based on isoniazid and acetyl-isoniazid pharmacokinetic data from seven studies with in total 466 patients from three continents. Three limited sampling strategies were tested based on the available sampling times in the dataset and practical considerations. The tested limited sampling strategies sampled at 2, 4, and 6 h, 2 and 4 h, and 2 h after dosing. The model-predicted area under the concentration-time curve from 0 to 24 h (AUC Performance of the developed model was acceptable and the uncertainty in parameter estimations was generally low (the highest relative standard error was 39% coefficient of variation). The limited sampling strategy with sampling at 2 and 4 h was determined as most suitable with an ME of 1.1% and RMSE of 23.4% for AUC A model-based therapeutic drug monitoring strategy for personalized dosing of isoniazid using sampling at 2 and 4 h after dosing was successfully developed. Prospective evaluation of this strategy will show how it performs in a clinical therapeutic drug monitoring setting.
Sections du résumé
BACKGROUND AND OBJECTIVE
This study aimed to develop and evaluate a population pharmacokinetic model and limited sampling strategy for isoniazid to be used in model-based therapeutic drug monitoring.
METHODS
A population pharmacokinetic model was developed based on isoniazid and acetyl-isoniazid pharmacokinetic data from seven studies with in total 466 patients from three continents. Three limited sampling strategies were tested based on the available sampling times in the dataset and practical considerations. The tested limited sampling strategies sampled at 2, 4, and 6 h, 2 and 4 h, and 2 h after dosing. The model-predicted area under the concentration-time curve from 0 to 24 h (AUC
RESULTS
Performance of the developed model was acceptable and the uncertainty in parameter estimations was generally low (the highest relative standard error was 39% coefficient of variation). The limited sampling strategy with sampling at 2 and 4 h was determined as most suitable with an ME of 1.1% and RMSE of 23.4% for AUC
CONCLUSIONS
A model-based therapeutic drug monitoring strategy for personalized dosing of isoniazid using sampling at 2 and 4 h after dosing was successfully developed. Prospective evaluation of this strategy will show how it performs in a clinical therapeutic drug monitoring setting.
Identifiants
pubmed: 33615419
doi: 10.1007/s40262-020-00971-2
pii: 10.1007/s40262-020-00971-2
pmc: PMC8249295
doi:
Substances chimiques
Isoniazid
V83O1VOZ8L
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
943-953Investigateurs
M J Boeree
(MJ)
E Burhan
(E)
R Dawson
(R)
A H Diacon
(AH)
S Gillespie
(S)
C M Mtabho
(CM)
N E Ntingiya
(NE)
N Heinrich
(N)
W Hoefsloot
(W)
M Hoelscher
(M)
G Kibiki
(G)
K Reither
(K)
I Sanne
(I)
H H Semvua
(HH)
A Tostmann
(A)
Commentaires et corrections
Type : ErratumIn
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