Evidence map›Paper›PMID 38580928›Full record

ArticleBMC medical research methodology2024

Bioequivalence trials for the approval of generic drugs in Saudi Arabia: a descriptive analysis of design aspects.

Turki A Althunian, Bader R Alzenaidy, Raseel A Alroba, Ohoud A Almadani, Fahad A Alqahtani, Albatool A Binajlan, Amal I Almousa, Deema K Alamr, Malak S Al-Mofada, Nora Y Alsaqer and 6 more

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Article in BMC medical research methodology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0citing papers in PubMed
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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

16 authors.

Turki A AlthunianResearch Informatics Department, Saudi Food and Drug Authority, Riyadh, Saudi Arabia. tathunian@sfda.gov.sa.ORCID 0000-0002-8030-7963
Bader R AlzenaidyDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Raseel A AlrobaResearch Informatics Department, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Ohoud A AlmadaniResearch Informatics Department, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Fahad A AlqahtaniDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Albatool A BinajlanDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Amal I AlmousaDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Deema K AlamrDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Malak S Al-MofadaDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Nora Y AlsaqerDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Hessa A AlarfajDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Abdulmohsen A BahlewaDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Mohammed A AlharbiDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Ali M AlhomaidanExecutive Department of Research and Studies, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Abdulaziz A AlsuwyehDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Abdulmohsen A AlsalehDepartment of Pharmacokinetics, Saudi Food and Drug Authority, Riyadh, Saudi Arabia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis retrospective analysis aimed to comprehensively review the design and regulatory aspects of bioequivalence trials submitted to the Saudi Food and Drug Authority (SFDA) since 2017.

methodsThis was a retrospective, comprehensive analysis study. The Data extracted from the SFDA bioequivalence assessment reports were analyzed for reviewing the overall design and regulatory aspects of the successful bioequivalence trials, exploring the impact of the coefficient of variation of within-subject variability (CVw) on some design aspects, and providing an in-depth assessment of bioequivalence trial submissions that were deemed insufficient in demonstrating bioequivalence.

resultsA total of 590 bioequivalence trials were included of which 521 demonstrated bioequivalence (440 single active pharmaceutical ingredients [APIs] and 81 fixed combinations). Most of the successful trials were for cardiovascular drugs (84 out of 521 [16.1%]), and the 2 × 2 crossover design was used in 455 (87.3%) trials. The sample size tended to increase with the increase in the CVw in trials of single APIs. Biopharmaceutics Classification System Class II and IV drugs accounted for the majority of highly variable drugs (58 out of 82 [70.7%]) in the study. Most of the 51 rejected trials were rejected due to concerns related to the study center (n = 21 [41.2%]).

conclusionThis comprehensive analysis provides valuable insights into the regulatory and design aspects of bioequivalence trials and can inform future research and assist in identifying opportunities for improvement in conducting bioequivalence trials in Saudi Arabia.

Indexed as

Drugs, GenericHumansRetrospective StudiesSample SizeSaudi ArabiaTherapeutic EquivalencyDrugs, GenericBioequivalence trialsClinical trialsGeneric drugsStudy design

Identifiers

PMID38580928
PMCPMC10996127

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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.