ArticleDrug, healthcare and patient safety2020
Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus.
Article in Drug, healthcare and patient safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
8 citing papers in PubMed, 10 citations in OpenAlex.
- Narrow Therapeutic Index Drugs: Regulatory Frameworks, Bioequivalence, and Model-Informed Precision Dosing.Pharmaceutics · 2026Review
- Localized Tacrolimus Delivery for Peripheral Nerve Regeneration: Molecular Mechanisms, Biomaterial Platforms, and Translational Strategies.International journal of molecular sciences · 2026Review
- Comparative bioequivalence of 1 mg and 4 mg tacrolimus extended-release tablets: randomized, open label, fully replicate, crossover trials in healthy adult subjects.Frontiers in nephrology · 2026Article
- Establishment of Biopredictive Dissolution and Bioequivalence Safe Space Using the Physiologically Based Biopharmaceutics Modeling for Tacrolimus Extended-Release Capsules.AAPS PharmSciTech · 2024Article
- Update on Maintenance Immunosuppression in Intestinal Transplantation.Gastroenterology clinics of North America · 2024Review
- Immunosuppression with Generics in Liver and Kidney Transplantation: A Real-World Evidence Study.Drug design, development and therapy · 2024Observational
- Physiologically based pharmacokinetic modeling of tacrolimus for food-drug and CYP3A drug-drug-gene interaction predictions.CPT: pharmacometrics & systems pharmacology · 2023Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Despite growing clinical confidence in generics and their potential to reduce long-term healthcare costs, the transplant community have had real concerns about the use of generic immunosuppressants. One such immunosuppressant is tacrolimus, a cornerstone of lifelong treatment for patients who have undergone a solid organ transplant. Tacrolimus has a narrow therapeutic index (NTI), giving rise to questions about the potential for clinically relevant altered drug exposure. Its use in transplant patients also gives rise to questions about the most discriminative subject population for bioequivalence studies. The recognised need for stringent criteria to support approval of generic drugs with an NTI led the European Medicines Association and Health Canada to provide detailed information on requirements for bioequivalence studies and introduce tighter bioequivalence limits for these drugs, including tacrolimus. The aim of this article is to illustrate how regulatory guidance is implemented during the clinical development of generic immunosuppressants, using a generic, once-daily prolonged-release formulation of tacrolimus as an example.
Indexed as
Identifiers
What OpenQuestion holds
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.