Handling interoccasion variability in model-based dose individualization using therapeutic drug monitoring data

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Abrantes, João A.Uppsala universitet,Institutionen för farmaceutisk biovetenskap (author)

Handling interoccasion variability in model-based dose individualization using therapeutic drug monitoring data

Article/chapterEnglish2019

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2019-04-29
John Wiley & Sons,2019
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LIBRIS-ID:oai:DiVA.org:uu-381215
https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-381215URI
https://doi.org/10.1111/bcp.13901DOI

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Language:English
Summary in:English

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Subject category:ref swepub-contenttype
Subject category:art swepub-publicationtype

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AIMS: This study aims to assess approaches to handle interoccasion variability (IOV) in a model-based therapeutic drug monitoring (TDM) context, using a population pharmacokinetic model of coagulation factor VIII as example.METHODS: We assessed five model-based TDM approaches: empirical Bayes estimates (EBEs) from a model including IOV, with individualized doses calculated based on individual parameters either (i) including or (ii) excluding variability related to IOV; and EBEs from a model excluding IOV by (iii) setting IOV to zero, (iv) summing variances of interindividual variability (IIV) and IOV into a single IIV term, or (v) re-estimating the model without IOV. The impact of varying IOV magnitudes (0-50%) and number of occasions/observations was explored. The approaches were compared with conventional weight-based dosing. Predictive performance was assessed with the prediction error (PE) percentiles.RESULTS: When IOV was lower than IIV, the accuracy was good for all approaches (50th percentile of the PE [P50] <7.4%), but the precision varied substantially between IOV magnitudes (P97.5 61-528%). Approach (ii) was the most precise forecasting method across a wide range of scenarios, particularly in case of sparse sampling or high magnitudes of IOV. Weight-based dosing led to less precise predictions than the model-based TDM approaches in most scenarios.CONCLUSIONS: Based on the studied scenarios and theoretical expectations, the best approach to handle IOV in model-based dose individualisation is to include IOV in the generation of the EBEs, but exclude the portion of unexplained variability related to IOV in the individual parameters used to calculate the future dose.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Medicinska och farmaceutiska grundvetenskaper Farmakologi och toxikologi hsv//swe
MEDICAL AND HEALTH SCIENCES Basic Medicine Pharmacology and Toxicology hsv//eng
NONMEM
pharmacokinetics
population analysis
therapeutic drug monitoring

Added entries (persons, corporate bodies, meetings, titles ...)

Jönsson, Siv,1963-Uppsala universitet,Institutionen för farmaceutisk biovetenskap(Swepub:uu)sivjonss (author)
Karlsson, MatsUppsala universitet,Institutionen för farmaceutisk biovetenskap(Swepub:uu)matskarl (author)
Nielsen, Elisabet I.,1973-Uppsala universitet,Institutionen för farmaceutisk biovetenskap(Swepub:uu)elnie838 (author)
Uppsala universitetInstitutionen för farmaceutisk biovetenskap (creator_code:org_t)

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In:British Journal of Clinical Pharmacology: John Wiley & Sons85:6, s. 1326-13360306-52511365-2125

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