Evidence map›Paper›PMID 35893811›Full record

ArticlePharmaceutics2022

Reconstructed Human Epidermis: An Alternative Approach for In Vitro Bioequivalence Testing of Topical Products.

Ana Sofia Agonia, Ana Palmeira-de-Oliveira, Catarina Cardoso, Cátia Augusto, Christian Pellevoisin, Christelle Videau, Ricardo Jorge Dinis-Oliveira, Rita Palmeira-de-Oliveira

Abstract read
In one paragraph

Article in Pharmaceutics, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

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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

8 authors.

Ana Sofia AgoniaLabfit-HPRD Health Products Research and Development, Lda, Edifício UBIMEDICAL Estrada Municipal 506, 6200-284 Covilhã, Portugal.
Ana Palmeira-de-OliveiraLabfit-HPRD Health Products Research and Development, Lda, Edifício UBIMEDICAL Estrada Municipal 506, 6200-284 Covilhã, Portugal.
Catarina CardosoLaboratórios Basi, Mortágua, Portugal, Parque Industrial Manuel Lourenço Ferreira, Lote 15, 3450-232 Mortágua, Portugal.
Cátia AugustoLaboratórios Basi, Mortágua, Portugal, Parque Industrial Manuel Lourenço Ferreira, Lote 15, 3450-232 Mortágua, Portugal.
Christian PellevoisinEPISKIN, EPISKIN 4, Rue Alexander Fleming, 69366 Lyon, France.ORCID 0000-0002-5431-1432
Christelle VideauEPISKIN, EPISKIN 4, Rue Alexander Fleming, 69366 Lyon, France.
Ricardo Jorge Dinis-OliveiraTOXRUN-Toxicology Research Unit, University Institute of Health Sciences (IUCS), Advanced Polytechnic and University Cooperative (CESPU), CRL, 4585-116 Gandra, Portugal.ORCID 0000-0001-7430-6297
Rita Palmeira-de-OliveiraLabfit-HPRD Health Products Research and Development, Lda, Edifício UBIMEDICAL Estrada Municipal 506, 6200-284 Covilhã, Portugal.ORCID 0000-0001-9311-8355

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The use of in vitro human skin permeation tests is of value when addressing the quality and equivalence of topical drug products in Europe and the US. Human skin is the membrane of choice for these studies. The use of human skin as a membrane is hindered by limited access, high variability of results, and limited applicability for drugs with low skin permeability. Reconstructed human epidermis (RhE) models are validated as skin surrogates for safety tests and have been explored for percutaneous absorption testing. Clotrimazole poorly permeates human skin and is widely available for topical treatments. In this study, clotrimazole creams were used to test the ability of RhE to be used as biological membrane for bioequivalence testing, based on the Draft Guideline on Quality and Equivalence of Topical Products (CHMP/QWP/708282/2018) using a discriminative and modified in vitro permeation test (IVPT). To fulfill the validation of a discriminatory method, Canesten

Indexed as

bioequivalence in vitrohuman skinpermeation testsreconstructed human epidermistopical products

Identifiers

PMID35893811
PMCPMC9331624

What OpenQuestion holds

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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.