Bioequivalence Evaluation of Topical Metronidazole Products Using Dermal Microdialysis in New Zealand Rabbits.

Sharareh Senemar, Benjamin A Kuzma, Tannaz Ramezanli, Priyanka Ghosh, Sam G Raney, Elena Rantou, Grazia Stagni

Abstract read

In one paragraph

Article in AAPS PharmSciTech, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it

0cells of the map it votes in

1citing papers in PubMed

0.2field-weighted citation impact, top 38% of its field

1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

Label-free quantification of topical drug permeation in skin using sparse spectral sampling stimulated Raman scattering imaging.Biophotonics discovery · 2026
Article

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 1 country.

Sharareh SenemarDivision of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University, 75 DeKalb Ave., Brooklyn, New York, 11201, USA.

Benjamin A KuzmaDivision of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University, 75 DeKalb Ave., Brooklyn, New York, 11201, USA.

Tannaz RamezanliOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Priyanka GhoshOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Sam G RaneyOffice of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA.

Elena RantouDivision of Biometrics VIII, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland, USA.

Grazia StagniDivision of Pharmaceutical Sciences, Arnold and Marie Schwartz College of Pharmacy, Long Island University, 75 DeKalb Ave., Brooklyn, New York, 11201, USA. gstagni@gmail.com.ORCID http://orcid.org/0000-0002-5991-2552

United States Food and Drug Administration · USLong Island University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Comparative assessment of cutaneous pharmacokinetics (cPK) by dermal microdialysis (dMD) appears to be suitable to evaluate the bioequivalence (BE) of topical dermatological drug products applied to the skin (TDDPs). Although dMD studies in the literature have reported inconclusive BE assessments, we have addressed several methodological deficiencies to improve dMD's capability to assess BE between reference (R) and approved generic (referred to as test (T)) gel and cream products of metronidazole (MTZ). The 90% confidence interval (CI) of the geometric mean ratios for the Ln(AUC

Indexed as

MetronidazoleSkinAnimalsArea Under CurveCross-Over StudiesDrugs, GenericMicrodialysisRabbitsTherapeutic EquivalencyDrugs, GenericMetronidazolebioavailabilitybioequivalencecutaneous pharmacokineticsdermal microdialysismetronidazole

Identifiers

PMID37789133

DOI10.1007/s11095-020-02920-x

OpenAlexW4387308268

What OpenQuestion holds

Textmetadata

Read underepoch 390

Registered trials

None linked

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.