ArticlePharmaceutical research2010
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.
Article in Pharmaceutical research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
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Who cites it
18 citing papers in PubMed.
- Characterizing Absorption Properties of Dispersible Pretomanid Tablets Using Population Pharmacokinetic Modelling.Clinical pharmacokinetics · 2022Trial
- 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
- Population pharmacokinetic and pharmacodynamic model-based comparability assessment of a recombinant human Epoetin Alfa and the Biosimilar HX575.Journal of clinical pharmacology · 2012Trial
- The Finite Absorption Time Concept Guiding Model Informed Drug & Generics Development in Clinical Pharmacology.Pharmaceutical research · 2025Review
- 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
- A Bayesian framework for virtual comparative trials and bioequivalence assessments.Frontiers in pharmacology · 2024Article
- Evaluation of model-based bioequivalence approach for single sample pharmacokinetic studies.CPT: pharmacometrics & systems pharmacology · 2023Article
- 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
- Trapezoid bioequivalence: A rational bioavailability evaluation approach on account of the pharmaceutical-driven balance of population average and variability.CPT: pharmacometrics & systems pharmacology · 2022Article
- Simulation Models for Prediction of Bioavailability of Medicinal Drugs-the Interface Between Experiment and Computation.AAPS PharmSciTech · 2022Review
- New Model-Based Bioequivalence Statistical Approaches for Pharmacokinetic Studies with Sparse Sampling.The AAPS journal · 2020Article
- Sensitivity of Pegfilgrastim Pharmacokinetic and Pharmacodynamic Parameters to Product Differences in Similarity Studies.The AAPS journal · 2019Article
- Design and inference for 3-stage bioequivalence testing with serial sampling data.Pharmaceutical statistics · 2018Article
- Comparison of non-compartmental and mixed effect modelling methods for establishing bioequivalence for the case of two compartment kinetics and censored concentrations.Journal of pharmacokinetics and pharmacodynamics · 2017Article
- Comparison of Nonlinear Mixed Effects Models and Noncompartmental Approaches in Detecting Pharmacogenetic Covariates.The AAPS journal · 2015Article
- Pharmacokinetic similarity of biologics: analysis using nonlinear mixed-effects modeling.Clinical pharmacology and therapeutics · 2012Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe main objective of this work is to compare the standard bioequivalence tests based on individual estimates of the area under the curve and the maximal concentration obtained by non-compartmental analysis (NCA) to those based on individual empirical Bayes estimates (EBE) obtained by nonlinear mixed effects models.
methodsWe evaluate by simulation the precision of sample means estimates and the type I error of bioequivalence tests for both approaches. Crossover trials are simulated under H ( 0 ) using different numbers of subjects (N) and of samples per subject (n). We simulate concentration-time profiles with different variability settings for the between-subject and within-subject variabilities and for the variance of the residual error.
resultsBioequivalence tests based on NCA show satisfactory properties with low and high variabilities, except when the residual error is high, which leads to a very poor type I error, or when n is small, which leads to biased estimates. Tests based on EBE lead to an increase of the type I error, when the shrinkage is above 20%, which occurs notably when NCA fails.
conclusionsFor small n or data with high residual error, tests based on a global data analysis should be considered instead of those based on individual estimates.
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