ArticleClinical pharmacology and therapeutics2012
Pharmacokinetic similarity of biologics: analysis using nonlinear mixed-effects modeling.
Article in Clinical pharmacology and therapeutics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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Who cites it
10 citing papers in PubMed.
- Model-Based Bioequivalence Analysis to Assess and Predict the Relative Bioavailability of Valproic Acid Formulations.European journal of drug metabolism and pharmacokinetics · 2024Trial
- Use of population approach non-linear mixed effects models in the evaluation of biosimilarity of monoclonal antibodies.European journal of clinical pharmacology · 2016Trial
- Population Pharmacokinetic Analysis of the Oral Absorption Process and Explaining Intra-Subject Variability in Plasma Exposures of Imatinib in Healthy Volunteers.European journal of drug metabolism and pharmacokinetics · 2016Trial
- Advancing Pharmacometrics in Africa: Insights and Perspectives From the 2025 Pharmacometrics Africa Conference.Clinical pharmacology and therapeutics · 2026Article
- 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
- Application of modified Michaelis - Menten equations for determination of enzyme inducing and inhibiting drugs.BMC pharmacology & toxicology · 2021Article
- 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
- Performing and interpreting individual pharmacokinetic profiles in patients with Hemophilia A or B: Rationale and general considerations.Research and practice in thrombosis and haemostasis · 2018Review
- Application of Pharmacometric Analysis in the Design of Clinical Pharmacology Studies for Biosimilar Development.The AAPS journal · 2018Article
- Review
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Authors and funding
7 authors.
Funding
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Abstract
Our objective was to show, using two examples, that a pharmacokinetic (PK) similarity analysis can be performed using nonlinear mixed-effects models (NLMEM). We used two studies that compared different biosimilars: a three-way crossover trial with somatropin and a parallel-group trial with epoetin-α. For both data sets, the results of NLMEM-based analysis were compared with those of noncompartmental analysis (NCA). For the latter analysis, we performed an NLMEM-based equivalence Wald test on secondary parameters of the model: the area under the curve and the maximal concentration. Somatropin PK was described by a one-compartment model and epoetin-α PK by a two-compartment model with linear and Michaelis-Menten elimination. For both studies, similarity of PK was demonstrated by means of both NCA and NLMEM, and both methods led to similar results. Therefore, for establishing similarity, PK data can be analyzed by either of the methods. NCA is an easier approach because it does not require data modeling; however, NLMEM leads to a better understanding of the underlying biological system.
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Registered trials
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