Evidence map›Paper›PMID 41754936›Full record

ReviewPharmaceutics2026

Refining Bioequivalence Assessment of Topical Drug Products for Local Action: A Comparative Analysis of Tape Stripping Methodologies.

Seeprarani Rath, Isadore Kanfer

Abstract readReview
In one paragraph

Review in Pharmaceutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

2 authors.

Seeprarani RathCenter for Dermal Research, Rutgers-The State University of New Jersey, 145 Bevier Road, Piscataway, NJ 08854, USA.ORCID 0000-0003-2216-1238
Isadore KanferBiopharmaceutics Research Institute, Rhodes University, Grahamstown 6139, South Africa.ORCID 0000-0002-4194-4273

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tape stripping (TS) is a minimally invasive technique that enables in vivo assessment of drug uptake in the skin of human subjects. Whilst appropriate for evaluating the bioequivalence (BE) of topical formulations, methodological variations persist, especially regarding the inclusion of clearance time measurements. This manuscript compares the TS protocols described in several publications, including the European Medicines Agency (EMA) and Japanese guidance, containing information relating to the evaluation of utility, practicality, and scientific validity. Evidence suggests that for drugs acting locally in the skin, clearance measurements that require time-consuming practical manipulation and subsequent complex data processing offer limited value, whereas single time point uptake studies, which are more convenient and expedient, may suffice for regulatory BE assessments. This discussion offers practical guidance for BE assessment of topical dermatological products and a more expedient approach using a single time point uptake study protocol, obviating the need for clearance time assessments.

Indexed as

dermatopharmacokinetics (DPK)locally acting topical drug productsskin thickness normalizationstratum corneum drug uptaketape strippingtopical bioequivalencetransepidermal water loss (TEWL)uptake-clearance (two time point) study designuptake-only (single time point) study design

Identifiers

PMID41754936
PMCPMC12944705

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Registered trials

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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.