ArticleJournal of pharmaceutical sciences2025
Biowaiver monograph for immediate-release solid oral dosage forms: Empagliflozin.
Article in Journal of pharmaceutical sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 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
2 citing papers in PubMed.
- Bioequivalence Evaluation of Immediate-Release Empagliflozin/Metformin Fixed-Dose Combination Tablets Under Fed Conditions in Healthy Mexican Subjects and Exploratory Analysis of Metformin Dose Proportionality.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Food-drug interactions of novel drugs used in cardiologic and diabetic patients - a PRISMA scoping review.Frontiers in pharmacology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors.
Funding
Abstract
The objective of this monograph is to assess the applicability of the BCS-based biowaiver for empagliflozin, a sodium glucose co-transporter (SGLT2) inhibitor indicated for the oral management of Type 2 diabetes mellitus. In this assessment, published evidence on membrane permeability, solubility, and formulation performance was examined to determine whether the BCS-based biowaiver can be applied. Empagliflozin is highly soluble but not highly permeable. Therefore, it was concluded that empagliflozin is a BCS class III drug. In cases where a test formulation has a formulation similar to that of the innovator product (Jardiance) and both formulations show very rapid dissolution with 85 % or more in 15 min, immediate-release solid oral formulation containing empagliflozin are eligible for a waiver of clinical studies. The ability to apply the biowaiver concept to empagliflozin, as proposed in this monograph, would contribute to the streamlined approval of generic versions of this essential medicine around the world.
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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.