Evidence map›Paper›PMID 31060289›Full record

ArticlePharmaceutics2019

In Silico Prediction of Plasma Concentrations of Fluconazole Capsules with Different Dissolution Profiles and Bioequivalence Study Using Population Simulation.

Marcelo Dutra Duque, Daniela Amaral Silva, Michele Georges Issa, Valentina Porta, Raimar Löbenberg, Humberto Gomes Ferraz

Abstract read
In one paragraph

Article in Pharmaceutics, 2019. 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

6 authors.

Marcelo Dutra DuqueDepartment of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo-SP 05508-000, Brazil. marcelo.duque@unifesp.br.
Daniela Amaral SilvaDepartment of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo-SP 05508-000, Brazil. amaralsi@ualberta.ca.
Michele Georges IssaDepartment of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo-SP 05508-000, Brazil. michelegeorges@usp.br.
Valentina PortaDepartment of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo-SP 05508-000, Brazil. vporta@usp.br.
Raimar LöbenbergFaculty of Pharmacy & Pharmaceutical Sciences, Katz Group-Rexall Centre for Pharmacy & Health Research, University of Alberta, 11361 ⁻ 87 Avenue, Edmonton, AB T6G 2E1, Canada. raimar@ualberta.ca.
Humberto Gomes FerrazDepartment of Pharmacy, Faculty of Pharmaceutical Sciences, Universidade de São Paulo-USP, Av. Prof. Lineu Prestes, 580, São Paulo-SP 05508-000, Brazil. sferraz@usp.br.

Funding

Conselho Nacional de Desenvolvimento Científico e Tecnológico 400455/2014-5Coordenação de Aperfeiçoamento de Pessoal de Nível Superior Finance Code 001
6 · The paper itself

Abstract

A biowaiver is accepted by the Brazilian Health Surveillance Agency (ANVISA) for immediate-release solid oral products containing Biopharmaceutics Classification System (BCS) class I drugs showing rapid drug dissolution. This study aimed to simulate plasma concentrations of fluconazole capsules with different dissolution profiles and run population simulation to evaluate their bioequivalence. The dissolution profiles of two batches of the reference product Zoltec

Indexed as

bioequivalenceBiopharmaceutics Classification System (BCS)biowaiverdissolutionfluconazoleGastroPlus™

Identifiers

PMID31060289
PMCPMC6571621

What OpenQuestion holds

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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.