ArticleBritish journal of clinical pharmacology2021
Validation of a perioperative population factor VIII pharmacokinetic model with a large cohort of pediatric hemophilia a patients.
Article in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed.
- Validation of a perioperative population factor VIII pharmacokinetic model with a large cohort of pediatric hemophilia a patients.British journal of clinical pharmacology · 2021Article
- Pharmacokinetics of perioperative FVIII in adult patients with haemophilia A: An external validation and development of an alternative population pharmacokinetic model.Haemophilia : the official journal of the World Federation of Hemophilia · 2021Article
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14 authors.
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Abstract
aimsPopulation pharmacokinetic (PK) models are increasingly applied to perform individualized dosing of factor VIII (FVIII) concentrates in haemophilia A patients. To guarantee accurate performance of a population PK model in dose individualization, validation studies are of importance. However, external validation of population PK models requires independent data sets and is, therefore, seldomly performed. Therefore, this study aimed to validate a previously published population PK model for FVIII concentrates administrated perioperatively.
methodsA previously published population PK model for FVIII concentrate during surgery was validated using independent data from 87 children with severe haemophilia A with a median (range) age of 2.6 years (0.03-15.2) and body weight of 14 kg (4-57). First, the predictive performance of the previous model was evaluated with MAP Bayesian analysis using NONMEM v7.4. Subsequently, the model parameters were (re)estimated using a combined dataset consisting of the previous modelling data and the data available for the external validation.
resultsThe previous model underpredicted the measured FVIII levels with a median of 0.17 IU mL
conclusionsThis study emphasizes the importance of external validation of population PK models using real-life data.
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