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drug interchangeability of generic and brand products of fixed dose combination tablets of sofosbuvir and ledipasvir 400 90 mg employment of reference scaled average bioequivalence study on healthy egyptian volunteers

descriptionPublicationkeyboard_double_arrow_right Article , Journal 07 Feb 2018Publisher:Springer Science and Business Media LLCJournal:Clinical Drug Investigation, volume 38, pages 439-448 (issn: 1173-2563, eissn: 1179-1918,

Authors: Ehab Rasmy Bendas; Mamdouh R. Rezk; Kamal A. Badr;

doi: 10.1007/s40261-018-0622-8

pmid: 29417463

drug interchangeability of generic and brand products of fixed dose combination tablets of sofosbuvir and ledipasvir 400 90 mg employment of reference scaled average bioequivalence study on healthy egyptian volunteers

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Abstract

The purpose of this study was to apply the reference-scaled average bioequivalence (RSABE) approach to evaluate the bioequivalence and to investigate the pharmacokinetic properties of two formulations of fixed dose combination (FDC) tablet of sofosbuvir (SOF) and ledipasvir (LED) (400/90 mg) in 36 healthy Egyptian volunteers.The study was performed in single-dose, randomized-sequence, open-label, reference-replicated, 3-period crossover design (RTR, TRR, RRT), with a washout period of 2 weeks. A rapid and simple LC-MS/MS method was developed and validated for the simultaneous estimation of SOF and LED using eplerenone as an internal standard (IS).The results showed that the 90% confidence intervals (CIs) for natural log-transformed ratios of CIn conclusion, bioequivalence between the two fixed-dose combination products was demonstrated for both active ingredients.

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Keywords

Adult, Male, Adolescent, Drug Compounding, Young Adult, Tandem Mass Spectrometry, Drugs, Generic, Humans, Fluorenes, Cross-Over Studies, Middle Aged, Reference Standards, Healthy Volunteers, Therapeutic Equivalency, Area Under Curve, Benzimidazoles, Drug Therapy, Combination, Egypt, Female, Sofosbuvir, Chromatography, Liquid, Tablets

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	citations This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).	6
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clinical medicine

Fields of Science

medical and health sciences

clinical medicine