ArticleJournal of pharmacokinetics and pharmacodynamics2008
An alternative method for population pharmacokinetic data analysis under noncompliance.
Article in Journal of pharmacokinetics and pharmacodynamics, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02348177 (A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir), which is not on this map. Cited by 13 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Pharmacokinetics Study Comparing Lopinavir Plasma Exposure When Given as Lopinavir/Ritonavir (1:1) in the Presence of Rifampicin and Lopinavir/Ritonavir (4:1) Without Rifampicin in HIV and TB Co-infected Children in South Africa.
Who cites it
13 citing papers in PubMed.
- Population pharmacokinetics of tenofovir and tenofovir-diphosphate in healthy women.Journal of clinical pharmacology · 2015Trial
- Estimation of tenofovir's population pharmacokinetic parameters without reliable dosing histories and application to tracing dosing history using simulation strategies.Journal of clinical pharmacology · 2014Trial
- Upholding or Breaking the Law of Superposition in Pharmacokinetics.Biomedicines · 2024Review
- Pharmacokinetic analysis across studies to drive knowledge-integration: A tutorial on individual patient data meta-analysis (IPDMA).CPT: pharmacometrics & systems pharmacology · 2023Article
- Challenges faced when modeling clinical toxicology and toxinology events.CPT: pharmacometrics & systems pharmacology · 2022Article
- Approaches to handling missing or "problematic" pharmacology data: Pharmacokinetics.CPT: pharmacometrics & systems pharmacology · 2021Article
- Handling Missing Dosing History in Population Pharmacokinetic Modeling: An Extension to MDM Method.CPT: pharmacometrics & systems pharmacology · 2019Article
- A pharmacometric case study regarding the sensitivity of structural model parameter estimation to error in patient reported dosing times.Journal of pharmacokinetics and pharmacodynamics · 2015Article
- Methods to detect non-compliance and reduce its impact on population PK parameter estimates.Journal of pharmacokinetics and pharmacodynamics · 2014Article
- Model-based approach for optimization of atazanavir dose recommendations for HIV-infected pediatric patients.Antimicrobial agents and chemotherapy · 2011Article
- Pharmacokinetically based estimation of patient compliance with oral anticancer chemotherapies: in silico evaluation.Clinical pharmacokinetics · 2009Article
- Contribution of the activities of CYP3A, CYP2D6, CYP1A2 and other potential covariates to the disposition of methadone in patients undergoing methadone maintenance treatment.British journal of clinical pharmacology · 2009Article
- Methods to account for inaccuracies in the dosing history when performing population pharmacokinetic analysis.Pharmaceutical research · 2008Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Noncompliance presents a persistent problem while analyzing PK data from outpatient clinical studies. Ignoring dose omission or making uninformed assumptions about patient drug intake history can prove detrimental to the objectives of the analysis (e.g. determining the PK model parameters or identifying covariates) and ultimately compromise the interpretation of the data. In order to overcome this problem, an alternative method of handling noncompliant data is evaluated in this report. The proposed approach is based on the principle of superposition and works by separating the estimation of the elimination rate from the model based steady-state PK concentration. Simulations implementing this method under different scenarios of noncompliance demonstrate that it performs better than the conventional method of analyzing population PK data when compared on the basis of bias and imprecision in parameter estimation and power (and type I error) for covariate detection. Overall, the new method exhibits great potential to address the issue of uncertain/unreliable dosing histories frequently encountered in clinical trials.
Indexed as
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.