ArticleClinical drug investigation2005
A survey of the quality of generic clarithromycin products from 18 countries.
Article in Clinical drug investigation, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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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.
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Who cites it
11 citing papers in PubMed.
- Quality of different brands of clarithromycin tablets marketed in Ethiopia; implications for the future.JAC-antimicrobial resistance · 2025Article
- Substandard and falsified antibiotics are associated with antimicrobial resistance: a retrospective country-level analysis.BMJ global health · 2025Article
- Antimicrobial drug pricing.Communications medicine · 2024Article
- Patient safety and public health concerns: poor dissolution rate of pioglitazone tablets obtained from China, Myanmar and internet sites.BMC pharmacology & toxicology · 2021Article
- Dissolution Edge Charts for Immediate Release Products and Their Applications: a Simulation Study to Aid the Setting of Specifications.The AAPS journal · 2019Article
- Levofloxacin: Insights Into Antibiotic Resistance and Product Quality.Frontiers in pharmacology · 2019Review
- Pharmaceutical Equivalence of Clarithromycin Oral Dosage Forms Marketed in Nairobi County, Kenya.Scientia pharmaceutica · 2017Article
- Substandard drugs: a potential crisis for public health.British journal of clinical pharmacology · 2014Review
- Effectiveness, safety and cost of drug substitution in hypertension.British journal of clinical pharmacology · 2010Article
- Pharmaceutical quality of nine generic orlistat products compared with Xenical(r).Obesity facts · 2010Article
- A survey of the quality of generic clarithromycin products from 18 countries.Clinical drug investigation · 2005Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis study compared the quality of 65 generic clarithromycin products manufactured in 18 countries with that of the innovator product.
designTo assess quality, the generic products were examined visually, assayed by high-pressure liquid chromatography for clarithromycin content and impurities, tested for dissolution properties, and compared with the innovator product manufactured by Abbott Laboratories.
resultsThis survey found that many generic clarithromycin products were not equivalent to the innovator product and many of these generic products fell short of the approved specifications developed for the innovator product. Overall, 9% (6 of 65) of all generic tablets tested failed to contain between 95% and 105% of the clarithromycin claimed in the label, thus falling short of the approved registered specification for the innovator product. Seventeen percent (1 of 6) of tablets from Latin America (LA), 8% (3 of 38) of tablets from the Asia, Africa, Pacific (AAP) region, and 10% (2 of 21) of tablets from Europe did not contain the amount of clarithromycin drug content claimed in the label. A total of 34% (17 of 50) of the generic products tested released less drug in 30 minutes than did the innovator tablets. Although the majority of these generic products met the dissolution specification requiring that 80% of the drug must dissolve in 30 minutes, one generic product failed to meet this specification with 68% of drug dissolving in 30 minutes. Moreover, 19% (12 of 65) of all the generic products tested exceeded the Abbott Laboratories' 3% limit for total impurities in bulk drug, and 30% (20 of 65) exceeded the Abbott Laboratories' 0.8% limit for the known impurity 6,11 di-O-methyl erythromycin A.
conclusionsThese results demonstrated that generic tablets are often not comparable in vitro to the innovator product. These findings suggest that results achieved with branded clarithromycin (Abbott Laboratories) should not be extrapolated to generic products. In vivo studies would be needed to determine the clinical relevance of these findings.
Identifiers
17523763What OpenQuestion holds
Registered trials
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.