Evidence map›Paper›PMID 35411510›Full record

ArticlePharmaceutical research2022

Investigator Impact on Reproducibility of Drug Bioavailability in Stratum Corneum Sampling by Tape Stripping.

Sagar Shukla, Annette L Bunge, Hazem E Hassan, Audra L Stinchcomb

Abstract read
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In one paragraph

Article in Pharmaceutical research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 68% 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

2 citing papers in PubMed, 1 citations in OpenAlex.

  1. Review
  2. 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

4 authors at 2 institutions in 2 countries.

Sagar ShuklaDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, 21201, USA.
Annette L BungeDepartment of Chemical and Biological Engineering, Colorado School of Mines, Golden, CO, 80401, USA.
Hazem E HassanDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, 21201, USA.
Audra L StinchcombDepartment of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore, MD, 21201, USA. astinchc@rx.umaryland.edu.ORCID http://orcid.org/0000-0001-7316-969X
University of Maryland, Baltimore · USColorado School of Mines · US

Funding

Bioequivalence of topical drug products: in vitro - in vivo correlationsU01FD004947 · FDA · UNIVERSITY OF MARYLAND BALTIMORE · PI BUNGE, ANNETTE L, DELGADO-CHARRO, M. BEGONA · 2013 to 2017
$2.3M
FDA HHS U01 FD004947U.S. Food and Drug Administration U01FD004947
6 · The paper itself

Abstract

purposeSkin sampling by tape stripping measures the local bioavailability of topical drug products in the stratum corneum (SC). The goal of the current study was to evaluate the impact of different investigators in studies that utilize a tape stripping protocol designed to minimize investigator variability.

methodsTwo open-label clinical studies compared two lidocaine patches and a diclofenac patch and solution in twelve healthy volunteers. The mass of drug was determined in SC samples collected on tape strips at three time points following product removal in duplicate by two investigators. Investigator results were compared with each other and with results for the diclofenac solution measured by another laboratory using a similar protocol.

resultsFor drug mass, the geometric mean ratio comparing two investigators is within the acceptable bioequivalence interval for most measurement times and drug products. Drug uptake into the SC from the diclofenac solution was not statistically different from that determined in another laboratory. The average flux from the SC over the clearance intervals for the four drug products correspond well with flux measurements from in vitro permeation tests.

conclusionsResults from different investigators are reproducible within the limitations of measurement variability, which can be managed by increasing volunteer numbers.

Indexed as

DiclofenacEpidermisBiological AvailabilityHumansReproducibility of ResultsSkinSkin AbsorptionDiclofenacDiclofenacLidocaineSkin samplingStratum corneumTape stripping

Identifiers

PMID35411510
OpenAlexW4223448262

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.