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Found 5 from your keywords: subject="Bioequivalence"
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Bioequivalence study of two clopidogrel film-coated tablet formulations in he…
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Setiawati A, et al

The present study was performed to compare the bioavailability of two clopidogrel 75 mg film-coated tablet formulations (test formulation and reference formulation). This study was a randomized, single-blind, two-period, two-sequence cross-over study which included 24 healthy adult male and female subjects under fasting condition. The pharmacokinetic parameters were assessed based on the concen…

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The importance of bioequivalence study: focus on clopidogrel
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Setiawati A

Bioequivalence (BE) study is required to show whether a generic copy product can be interchangeable with the brand innovator product. The aim of this article is to provide the rationale for conducting BE studies, the main products requiring BE studies, the design and conduct of BE studies in general, with focus on clopidogrel. All of the clopidogrel generic products in Indonesia have been shown…

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Bioequivalence Study of Dapagliflozin 10 mg Film Coated Tablets in Healthy In…
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Tjandrawinata RR

This study aimed to demonstrate the bioequivalence of the Dapagliflozin 10 mg film-coated tablets manufactured by PT Dexa Medica, Indonesia, in comparison with the reference formulation, Forxiga® 10 mg filmcoated tablets, manufactured by AstraZeneca Pharmaceuticals

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Etoricoxib Coated Tablets: Bioequivalence Assessment between Two Formulations…
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Meulman J

Etoricoxib is a non-steroidal anti-inflammatory drug with high selectivity for cyclooxygenase 2 (COX-2), exerting a pronounced anti-inflammatory effect with fewer adverse events when compared to COX-1 inhibitors. The present study aimed to evaluate the bioequivalence between two etoricoxib-coated tablet formulations to meet regulatory requirements for a branded generic product registration in B…

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Bioequivalence study of two formulations of candesartan cilexetil tablet in h…
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Tjandrawinata RR

This study was a randomized, single- blind, two-period, cross-over study which included 24 healthy adult male and female subjects under fasting conditions. The pharmacokinetic parameters were determined based on the concentrations of candesartan (CAS 139481-59-7), using ultra-pressure high-performance liquid chromatography with a tandem mass spectrometer detector. In each of the two study perio…

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