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They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans. For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve.
Approval has been based on bioequivalence with the FDA stating that the effectiveness of Radicava ORS is based on a study showing comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. This is administered according to the same treatment regimen as for the IV infusion.
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