ReviewFrontiers in pharmacology2024
Update on the advances and challenges in bioequivalence testing methods for complex topical generic products.
Review in Frontiers in pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Film-Forming Gels for Topical Drug Delivery: A Systematic Review of the Effects of Formulation on Film Performance, Drug Release, and Skin Permeation.Drug design, development and therapy · 2026Pooled it
- Engineering skin microphysiological systems for transdermal drug screening based on strategic model selection and quantitative prediction roadmaps.Materials today. Bio · 2026Review
- Microstructural Characterization and In Vitro-In Vivo Evaluation of Drug Release and Permeation in Goupi Plaster.Pharmaceutics · 2026Article
- Regulation for the Bioequivalence Evaluation of Generic Topical Dermatological Drug Products in Japan.European journal of drug metabolism and pharmacokinetics · 2025Article
- From In Vivo Predictive Dissolution to Virtual Bioequivalence: A GastroPlusPharmaceuticals (Basel, Switzerland) · 2025Article
- Advancements in Virtual Bioequivalence: A Systematic Review of Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry.Pharmaceutics · 2024Review
- Generic orphan drug substitution: a critical analysis of global practices and Saudi Arabia's perspective.Frontiers in pharmacology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Most of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence. The evaluation of bioequivalence for complex topical dermatological formulations is a challenging task that requires careful consideration of several factors. Although comparative clinical studies are still considered the gold standard approach for establishing bioequivalence in most formulations, these studies can be costly and insensitive to detect formulation differences. Therefore, significant efforts have been made to develop and validate alternative approaches that demonstrate bioequivalence and expedite the availability of high-quality generic topical dermatological products. This article reviews the current methods for determining the bioequivalence of topical formulations in humans, with particular emphasis on recent advances in these methodologies. Most of the alternative methods are sensitive and reproducible, with the capability to ease the financial burden of comparative clinical studies within a short delivery time. The limitations associated with each technique are reviewed in detail.
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.