ArticleJournal of pharmacokinetics and pharmacodynamics2004
Statistical issues in a modeling approach to assessing bioequivalence or PK similarity with presence of sparsely sampled subjects.
Article in Journal of pharmacokinetics and pharmacodynamics, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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Who cites it
13 citing papers in PubMed.
- Population pharmacokinetic and pharmacodynamic model-based comparability assessment of a recombinant human Epoetin Alfa and the Biosimilar HX575.Journal of clinical pharmacology · 2012Trial
- An Open-Source Framework for Virtual Bioequivalence Modeling and Clinical Trial Design.CPT: pharmacometrics & systems pharmacology · 2025Article
- Evaluation of model-integrated evidence approaches for pharmacokinetic bioequivalence studies using model averaging methods.CPT: pharmacometrics & systems pharmacology · 2024Article
- Development and comparison of model-integrated evidence approaches for bioequivalence studies with pharmacokinetic end points.CPT: pharmacometrics & systems pharmacology · 2024Article
- Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies.Journal of pharmacokinetics and pharmacodynamics · 2022Article
- Population pharmacokinetics of adalimumab biosimilar adalimumab-adbm and reference product in healthy subjects and patients with rheumatoid arthritis to assess pharmacokinetic similarity.British journal of clinical pharmacology · 2020Article
- Exposure-response modeling of clinical end points using latent variable indirect response models.CPT: pharmacometrics & systems pharmacology · 2014Article
- Pharmacokinetic similarity of biologics: analysis using nonlinear mixed-effects modeling.Clinical pharmacology and therapeutics · 2012Article
- Bioequivalence tests based on individual estimates using non-compartmental or model-based analyses: evaluation of estimates of sample means and type I error for different designs.Pharmaceutical research · 2010Article
- Non-compartmental estimation of pharmacokinetic parameters in serial sampling designs.Journal of pharmacokinetics and pharmacodynamics · 2009Article
- Establishing bioequivalence in serial sacrifice designs.Journal of pharmacokinetics and pharmacodynamics · 2007Article
- Fosamprenavir : clinical pharmacokinetics and drug interactions of the amprenavir prodrug.Clinical pharmacokinetics · 2006Review
- Pharmacokinetic and pharmacodynamic population modeling of orally administered rabeprazole in healthy Chinese volunteers by the NONMEM method.European journal of drug metabolism and pharmacokineticsArticle
Corrections and comments
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Authors and funding
4 authors.
Funding
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Abstract
Drug development at different stages may require assessment of similarity of pharmacokinetics (PK). The common approach for such assessment when the difference is drug formulation is bioequivalence (BE), which employs a hypothesis test based on the evaluation of a 90% confidence interval for the ratio of average pharmacokinetic (PK) parameters. The role of formulation effect in BE assessment is replaced by subject population in PK similarity assessment. The traditional approach for BE requires that the PK parameters, primarily AUC and Cmax, be obtained from every individual. Unfortunately in many clinical circumstances, some or even all of the individuals may be sparsely sampled, making the individual evaluation difficult. In such cases, using models, particularly population models, becomes appealing. However, conducting an appropriate statistical test based on population modeling in a form consistent, at least in principle, with traditional 90% confidence interval approach is not so straightforward as it may appear. This manuscript proposes one such approach that can be applied to sparse sampling situations. The approach aims to maintain, as much as possible, the appropriateness of the hypothesis test. It is applied to data from clinical studies to address a need in drug development for assessment of PK similarity in different populations.
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