Journal of Bioequivalence & Bioavailability

Mouna Sassi MD

Publications

• Research Article
  Generic and Branded Enoxaparin Bioequivalence: A Clinical and Experimental Study
  Author(s): Hamdi Boubaker MD, Mohamed Habib Grissa MD, Mouna Sassi MD, Taher Chakroun MD, Kaouthar Beltaief MD, Mohsen Hassine MD, Grigoris T Gerotziafas MD, Rabie Razgallah MD, Wahid Bouida MD, Riadh Boukef MD, Ismail Elalamy MD and Semir Nouira MDHamdi Boubaker MD, Mohamed Habib Grissa MD, Mouna Sassi MD, Taher Chakroun MD, Kaouthar Beltaief MD, Mohsen Hassine MD, Grigoris T Gerotziafas MD, Rabie Razgallah MD, Wahid Bouida MD, Riadh Boukef MD, Ismail Elalamy MD and Semir Nouira MD
  
  Our aim is to compare a new generic version of enoxaparin (Enoxa®) with the parent brand (Lovenox®). We included patients with acute coronary syndrome (ACS) for the clinical study and healthy volunteers for the experimental study. ACS patients randomly assigned to receive a bolus of Enoxa® (n=86) or Lovenox® (n=83) and serum anti-Xa activity was measured 4 hours thereafter. For experimental study, blood from healthy volunteers was used to compare the effect of both formulations on thrombin generation in citrated platelet-poor plasma (PPP). The half maximal inhibitory concentration of the drug (IC50) that is required to inhibit 50% in-vitro thrombin generation parameters, mean rate index (MRI) and endogenous thrombin potential (ETP). Both IC50 MRI and IC50 ETP were calculated in PPP. In ACS patients, serum anti-Xa activity was found not different between Enoxa® and .. View More»
  DOI: 10.4172/jbb.1000244

  Abstract PDF