Rivaroxaban bioequivalence studies

We have conducted in total 5 bioequivalence studies with rivaroxaban. The studies involved cohorts with healthy volunteers, age 18-55, males and females who were admitted to the site for two periods.

 

Rivaroxaban is a factor Xa inhibitor used to treat deep vein thrombosis (DVT) and pulmonary embolism (PE). May also be used as thrombosis prophylaxis in specific situations.

Rivaroxaban is in advanced clinical development for the prevention and treatment of thromboembolic disorders. Oral rivaroxaban may be given in fixed once-daily doses, with the potential for no coagulation monitoring. These properties, along with results from preclinical and clinical studies, suggest that rivaroxaban may have advantages over current treatments. Studies in arterial and venous animal models demonstrated that rivaroxaban has potent antithrombotic effects, without prolonging bleeding times.

 

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Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic

BioResearch is following  new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic..

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BRG update on COVID-19

Dear Investigators and Researchers.
In recent days, the whole world is providing heroic fight with the SARS-CoV-2 virus.

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International Clinical Trials Day

On 28th of June, 2019 we attended the annual conference on the occassion of International Clinical Trials Day titled "On the verge of changes".

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TransCelerate accreditation

To improve our trainings system, we joined „GCP Mutual Recognition Program" and were accredited by TransCelerate Biopharma Inc

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