Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study.

التفاصيل البيبلوغرافية
العنوان: Interchangeability of gabapentin generic formulations in the Netherlands: a comparative bioavailability study.
المؤلفون: Yu, Y.
Added Details: Teerenstra, S. author.
Vanmolkot, F. author.
Neef, C. author.
Burger, D.M. author.
Maliepaard, M. author.
وصف مادي: 1 online resource
الموضوعات: N4i 3: Poverty-related infectious diseases NCEBP 13: Infectious diseases and international health., NCEBP 2: Evaluation of complex medical interventions., NCEBP 6: Quality of nursing and allied health care., NCMLS 5: Membrane transport and intracellular motility IGMD 9: Renal disorder.
مصطلحات الفهرس: Article / Letter to editor.
URL: http://hdl.handle.net/2066/119121
https://doi.org/10.1038/clpt.2013.108
الاتاحة: Open access content. Open access content.
ملاحظة: Clinical Pharmacology and Therapeutics, 94, 4, pp. 519-24.
Item does not contain fulltext.
To investigate the so-called "drift" with generic-generic drug substitution, a single-dose, four-way crossover comparative bioavailability study was performed involving 24 healthy subjects and three generic and one branded formulation of a tablet containing 800 mg gabapentin as test medication. The results showed that the 90% confidence intervals (CIs) for the area under the drug concentration-time curve (AUC0-t) and for the peak drug concentration (Cmax) were within the acceptance range of 80-125% for all comparisons. The safety profiles of the different gabapentin formulations were comparable. To conclude, all three generic formulations of gabapentin were found to be bioequivalent with the branded formulation and with each other, indicating that the formulations are interchangeable. These results strongly indicate the absence of "drift" with gabapentin generic-generic substitution.Clinical Pharmacology & Therapeutics (2013); 94 4, 519-524. doi:10.1038/clpt.2013.108.
Other Numbers: NLQGE oai:repository.ubn.ru.nl:2066/119121
1443206528
المصدر المساهم: From OAIster®, provided by the OCLC Cooperative.
رقم الانضمام: edsoai.on1443206528
قاعدة البيانات: OAIster