Evidence map›Paper›PMID 31140620›Full record

ArticleBritish journal of clinical pharmacology2019

Adjusted indirect comparisons to assess bioequivalence between generic clopidogrel products in Serbia.

Zorica Pejčić, Katarina Vučićević, Alfredo García-Arieta, Branislava Miljković

Abstract readComparative Study
In one paragraph

Article in British journal of clinical pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
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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

4 authors.

Zorica PejčićMedicines and Medical Devices Agency of Serbia, Belgrade, Republic of Serbia.
Katarina VučićevićDepartment of Pharmacokinetics and Clinical Pharmacy, University of Belgrade - Faculty of Pharmacy, Belgrade, Republic of Serbia.ORCID 0000-0001-9676-5785
Alfredo García-ArietaDivision of Pharmacology and Clinical Evaluation Department of Human Use Medicines, Spanish Agency for Medicines and Health Care Products, Madrid, Spain.ORCID 0000-0002-9702-6973
Branislava MiljkovićDepartment of Pharmacokinetics and Clinical Pharmacy, University of Belgrade - Faculty of Pharmacy, Belgrade, Republic of Serbia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsGeneric products can be regarded as therapeutically equivalent and switchable with the reference product. However, switchability between generics is unknown, as direct comparisons between generics are not performed. The aim of this study was to investigate the bioequivalence between generic clopidogrel products by means of adjusted indirect comparisons (AICs).

methodsAICs were conducted to assess bioequivalence between 4 generic clopidogrel products that are authorised in Serbia. Generics are considered equivalent to the reference if the 90% confidence intervals (CIs) for the ratios test/reference of the maximum concentration (C

resultsThe 90% CIs of the AICs demonstrated bioequivalence within 80.00-125.00% for all AUC

conclusionThis study demonstrates that the bioavailability of these 4 generic clopidogrel products authorised in Serbia is very similar. Despite the limited power of AICs, bioequivalence was demonstrated for all 90% CIs of AUC

Indexed as

Area Under CurveBiological AvailabilityClopidogrelDrugs, GenericHumansPlatelet Aggregation InhibitorsSerbiaTherapeutic EquivalencyClopidogrelDrugs, GenericPlatelet Aggregation Inhibitorsbioequivalencegeneric-generic substitutioninterchangeabilityswitchabilitytherapeutic equivalence

Identifiers

PMID31140620
PMCPMC6710521

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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.