FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2103117079> ?p ?o ?g. }

• W2103117079 abstract "Existence of anti-malarial generic drugs with low bioavailability marketed on sub-Saharan Africa raises a concern on patients achieving therapeutic concentrations after intake of such products. This work compared bioavailability of one generic tablet formulation with innovator's product. Both were fixed dose combination tablet formulations containing artemether and lumefantrine.The study was conducted in Dar Es Salaam, Tanzania, in which a survey of the most abundant generic containing artemether-lumefantrine tablet formulation was carried out in retail pharmacies. The most widely available generic (Artefan®, Ajanta Pharma Ltd, Maharashtra, India) was sampled for bioavailability comparison with Coartem® (Novartis Pharma, Basel, Switzerland)--the innovator's product. A randomized, two-treatment cross-over study was conducted in 18 healthy Tanzanian black male volunteers. Each volunteer received Artefan® (test) and Coartem® (as reference) formulation separated by 42 days of drug-free washout period. Serial blood samples were collected up to 168 hours after oral administration of a single dose of each treatment. Quantitation of lumefantrine plasma levels was done using HPLC with UV detection. Bioequivalence of the two products was assessed in accordance with the US Food and Drug Authority (FDA) guidelines.The most widely available generic in pharmacies was Artefan® from India. All eighteen enrolled volunteers completed the study and both test and reference tablet formulations were well tolerated. It was possible to quantify lumefantrine alone, therefore, the pharmacokinetic parameters reported herein are for lumefantrine. The geometric mean ratios for Cmax, AUC0-t and AUC0-∞ were 84% in all cases and within FDA recommended bioequivalence limits of 80%-125%, but the 90% confidence intervals were outside FDA recommended limits (CI 49-143%, 53-137%, 52-135% respectively). There were no statistical significant differences between the two formulations with regard to PK parameters (P > 0.05).Although the ratios of AUCs and Cmax were within the acceptable FDA range, bioequivalence between Artefan® and Coartem® tablet formulations was not demonstrated due to failure to comply with the FDA 90% confidence interval criteria. Based on the observed total drug exposure (AUCs), Artefan® is likely to produce a similar therapeutic response as Coartem®." @default.
• W2103117079 created "2016-06-24" @default.
• W2103117079 creator A5008158823 @default.
• W2103117079 creator A5035845606 @default.
• W2103117079 creator A5037005894 @default.
• W2103117079 creator A5043860389 @default.
• W2103117079 creator A5060657310 @default.
• W2103117079 creator A5064043967 @default.
• W2103117079 creator A5071929032 @default.
• W2103117079 creator A5076721850 @default.
• W2103117079 creator A5080121371 @default.
• W2103117079 date "2013-05-30" @default.
• W2103117079 modified "2023-10-16" @default.
• W2103117079 title "Comparison of bioavailability between the most available generic tablet formulation containing artemether and lumefantrine on the Tanzanian market and the innovator’s product" @default.
• W2103117079 cites W1527428657 @default.
• W2103117079 cites W1955275162 @default.
• W2103117079 cites W1965141592 @default.
• W2103117079 cites W1975685280 @default.
• W2103117079 cites W2035747470 @default.
• W2103117079 cites W2050832165 @default.
• W2103117079 cites W2060317640 @default.
• W2103117079 cites W2064855181 @default.
• W2103117079 cites W2085556453 @default.
• W2103117079 cites W2096086340 @default.
• W2103117079 cites W2097260567 @default.
• W2103117079 cites W2112261944 @default.
• W2103117079 cites W2115417394 @default.
• W2103117079 cites W2127154308 @default.
• W2103117079 cites W2161311583 @default.
• W2103117079 cites W2170682688 @default.
• W2103117079 cites W2184920920 @default.
• W2103117079 cites W3122758023 @default.
• W2103117079 doi "https://doi.org/10.1186/1475-2875-12-174" @default.
• W2103117079 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/3669611" @default.
• W2103117079 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/23718725" @default.
• W2103117079 hasPublicationYear "2013" @default.
• W2103117079 type Work @default.
• W2103117079 sameAs 2103117079 @default.
• W2103117079 citedByCount "16" @default.
• W2103117079 countsByYear W21031170792014 @default.
• W2103117079 countsByYear W21031170792015 @default.
• W2103117079 countsByYear W21031170792016 @default.
• W2103117079 countsByYear W21031170792017 @default.
• W2103117079 countsByYear W21031170792018 @default.
• W2103117079 countsByYear W21031170792019 @default.
• W2103117079 countsByYear W21031170792020 @default.
• W2103117079 countsByYear W21031170792021 @default.
• W2103117079 crossrefType "journal-article" @default.
• W2103117079 hasAuthorship W2103117079A5008158823 @default.
• W2103117079 hasAuthorship W2103117079A5035845606 @default.
• W2103117079 hasAuthorship W2103117079A5037005894 @default.
• W2103117079 hasAuthorship W2103117079A5043860389 @default.
• W2103117079 hasAuthorship W2103117079A5060657310 @default.
• W2103117079 hasAuthorship W2103117079A5064043967 @default.
• W2103117079 hasAuthorship W2103117079A5071929032 @default.
• W2103117079 hasAuthorship W2103117079A5076721850 @default.
• W2103117079 hasAuthorship W2103117079A5080121371 @default.
• W2103117079 hasBestOaLocation W21031170791 @default.
• W2103117079 hasConcept C10138342 @default.
• W2103117079 hasConcept C112705442 @default.
• W2103117079 hasConcept C144133560 @default.
• W2103117079 hasConcept C181389837 @default.
• W2103117079 hasConcept C203014093 @default.
• W2103117079 hasConcept C22979827 @default.
• W2103117079 hasConcept C2776120307 @default.
• W2103117079 hasConcept C2776396487 @default.
• W2103117079 hasConcept C2776473838 @default.
• W2103117079 hasConcept C2778048844 @default.
• W2103117079 hasConcept C2778371730 @default.
• W2103117079 hasConcept C2778629330 @default.
• W2103117079 hasConcept C2780035454 @default.
• W2103117079 hasConcept C2780780316 @default.
• W2103117079 hasConcept C42404028 @default.
• W2103117079 hasConcept C71924100 @default.
• W2103117079 hasConcept C84309077 @default.
• W2103117079 hasConcept C98274493 @default.
• W2103117079 hasConceptScore W2103117079C10138342 @default.
• W2103117079 hasConceptScore W2103117079C112705442 @default.
• W2103117079 hasConceptScore W2103117079C144133560 @default.
• W2103117079 hasConceptScore W2103117079C181389837 @default.
• W2103117079 hasConceptScore W2103117079C203014093 @default.
• W2103117079 hasConceptScore W2103117079C22979827 @default.
• W2103117079 hasConceptScore W2103117079C2776120307 @default.
• W2103117079 hasConceptScore W2103117079C2776396487 @default.
• W2103117079 hasConceptScore W2103117079C2776473838 @default.
• W2103117079 hasConceptScore W2103117079C2778048844 @default.
• W2103117079 hasConceptScore W2103117079C2778371730 @default.
• W2103117079 hasConceptScore W2103117079C2778629330 @default.
• W2103117079 hasConceptScore W2103117079C2780035454 @default.
• W2103117079 hasConceptScore W2103117079C2780780316 @default.
• W2103117079 hasConceptScore W2103117079C42404028 @default.
• W2103117079 hasConceptScore W2103117079C71924100 @default.
• W2103117079 hasConceptScore W2103117079C84309077 @default.
• W2103117079 hasConceptScore W2103117079C98274493 @default.
• W2103117079 hasIssue "1" @default.
• W2103117079 hasLocation W21031170791 @default.
• W2103117079 hasLocation W21031170792 @default.
• W2103117079 hasLocation W21031170793 @default.
• W2103117079 hasLocation W21031170794 @default.
• W2103117079 hasOpenAccess W2103117079 @default.

• next