ArticleEuropean journal of clinical pharmacology2015
Investigation into the interchangeability of generic formulations using immunosuppressants and a broad selection of medicines.
Article in European journal of clinical pharmacology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The trial behind it
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Who cites it
9 citing papers in PubMed.
- Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs.BMC pharmacology & toxicology · 2017Trial
- Does the placebo effect modulate drug bioavailability? Randomized cross-over studies of three drugs.Journal of negative results in biomedicine · 2017Trial
- Drug Brand Switching: A Regulatory Perspective.Drug safety · 2026Review
- The use of GA-RxODE (Genetics Algorithms and Running simulations from Ordinary Differential Equations-based model) method to optimize bioequivalence studies.Pharmacology research & perspectives · 2021Review
- Pharmacokinetics and Generic Drug Switching: A Regulator's View.Clinical pharmacokinetics · 2020Article
- Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia.British journal of clinical pharmacology · 2019Article
- Interchangeability of Generics-Experiences and Outlook Toward Pharmacokinetics Variability and Generic-Generic Substitution.Clinical pharmacology and therapeutics · 2019Article
- Evaluating the Feasibility of Use of a Foreign Reference Product for Generic Drug Applications: A Retrospective Pilot Study.European journal of drug metabolism and pharmacokinetics · 2017Article
- Prescription writing: Generic or brand?Indian journal of psychiatryArticle
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo date, the interchangeability of generic drugs has only been investigated for a limited number of medicines. The objective of this study was to investigate generic-generic drug interchangeability in a large subset of generic formulations in order to cover a broad spectrum of drugs.
methodsOrally administered drugs for investigation in this study were selected using strict, predefined criteria, with the purpose to avoid bias. This selection procedure yielded atorvastatin, bicalutamide, naratriptan, olanzapine, perindopril, and venlafaxine. Further, ciclosporin, tacrolimus, and mycophenolate mofetil were investigated as test immunosuppressants. Adjusted indirect comparisons were conducted between generic drugs containing the same active substance, and the 90% confidence interval (CI) for AUC and Cmax was calculated.
resultsIn total, 120 bioequivalence studies were identified in the Dutch medicine regulatory agency's database, allowing 292 indirect comparisons between generic drugs. The indirect comparison results indicated that in the vast majority of cases, i.e., 80.5%, the 90% CIs for both AUCt and Cmax fell within the bioequivalence criteria (in 90.1 and 87.0% for AUCt and Cmax, respectively). In 1% of the 292 indirect comparison for AUCt and 3% for Cmax, a wider range of 75-133% (or 80-125%) was exceeded.
conclusionsOverall, our study suggests that exposure-related risks associated with the exchange of different generic drugs in clinical practice are not increased to a relevant extent compared to the situation in which a generic is exchanged with the innovator.
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