New product-specific bioequivalence guidance
نویسندگان
چکیده
منابع مشابه
Bioequivalence evaluation of a triamterene-hydrochlorothiazide generic product: a new bioequivalence index for fixed-dose combinations.
In this study, an open, double-blind, randomized, two-period, two-group crossover design was conducted in 14 healthy volunteers to study the bioequivalence of a fixed-dose generic product. After administration of test or reference products to each volunteer, both active ingredients were determined simultaneously in plasma samples using a developed and validated HPLC-UV method, and pharmacokinet...
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The pharmacokinetics of olanzapine are linear and doseproportional within the approved dosage range from 1 mg up to 20 mg. Olanzapine is well absorbed following oral administration in both fed and fasted states . Food does not affect the rate or the extent of olanzapine absorption. Time of peak concentration ranges from 2-7 h [4,5]. Olanzapine is extensively distributed throughout the body, bin...
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ژورنال
عنوان ژورنال: Generics and Biosimilars Initiative Journal
سال: 2014
ISSN: 2033-6403,2033-6772
DOI: 10.5639/gabij.2014.0301.009