Evidence map›Paper›PMID 31835294›Full record

ArticlePharmaceutics2019

Investigation to Explain Bioequivalence Failure in Pravastatin Immediate-Release Products.

Alejandro Ruiz-Picazo, Sarin Colón-Useche, Blanca Perez-Amorós, Marta González-Álvarez, Irene Molina-Martínez, Isabel González-Álvarez, Alfredo García-Arieta, Marival Bermejo

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 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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

5 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Article
  5. 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

8 authors.

Alejandro Ruiz-PicazoEngineering, Pharmacokinetics and Pharmaceutical Technology Area, Miguel Hernandez University, 03550 San Juan de Alicante, Spain.
Sarin Colón-UsecheEngineering, Pharmacokinetics and Pharmaceutical Technology Area, Miguel Hernandez University, 03550 San Juan de Alicante, Spain.
Blanca Perez-AmorósEngineering, Pharmacokinetics and Pharmaceutical Technology Area, Miguel Hernandez University, 03550 San Juan de Alicante, Spain.
Marta González-ÁlvarezEngineering, Pharmacokinetics and Pharmaceutical Technology Area, Miguel Hernandez University, 03550 San Juan de Alicante, Spain.
Irene Molina-MartínezPharmacokinetics and Pharmaceutical Technology, Complutense University of Madrid, 28040 Madrid, Spain.
Isabel González-ÁlvarezEngineering, Pharmacokinetics and Pharmaceutical Technology Area, Miguel Hernandez University, 03550 San Juan de Alicante, Spain.ORCID 0000-0002-1685-142X
Alfredo García-ArietaService on Pharmacokinetics and Generic Medicines, Division of Pharmacology and Clinical Evaluation, Department of Human Use Medicines, Spanish Agency for Medicines and Health Care Products, 28022 Madrid, Spain.ORCID 0000-0002-9702-6973
Marival BermejoEngineering, Pharmacokinetics and Pharmaceutical Technology Area, Miguel Hernandez University, 03550 San Juan de Alicante, Spain.ORCID 0000-0001-5022-0544

Funding

European Regional Development Fund SAF2016-78756(AEI/FEDER, EU)
6 · The paper itself

Abstract

The purpose of this work is to explore the predictive ability of the biopharmaceutics classification system (BCS) biowaiver based on the dissolution methods for two pravastatin test products, where one of them showed bioequivalence (BE) while the other test failed (non-bioequivalence, or NBE), and to explore the reasons for the BE failure. Experimental solubility and permeability data confirmed that pravastatin is a BCS class III compound. The permeability experiments confirmed that the NBE formulation significantly increased pravastatin permeability, and could explain its higher absorption rate and higher C

Indexed as

bioequivalenceBiopharmaceutics Classification Systemdissolution testin vitropravastatin

Identifiers

PMID31835294
PMCPMC6956045

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.