Journal of Bioequivalence & Bioavailability

Mohamed Zilli

Publications

• Research Article
  Comparability of “Enoxamed” a Tunisian Generic Enoxaparin with the Originator Product: Non-clinical and Clinical Studies
  Author(s): Mouna Sassi, Kaouther Beltaief, Habib Haouala, Sondes Kraiem, Samir Kammoun, Faouzi Maatoug, Gouider Jeridi, Mohsen Hassine, Mahdi Methammem, Ibrahim Nciri, Sofiane Kammoun, Mohamed Zilli, Mondher Kortas, Mohamed Habib Grissa, Ismail Elalamy, Wahid Bouida M and Semir NouiraMouna Sassi, Kaouther Beltaief, Habib Haouala, Sondes Kraiem, Samir Kammoun, Faouzi Maatoug, Gouider Jeridi, Mohsen Hassine, Mahdi Methammem, Ibrahim Nciri, Sofiane Kammoun, Mohamed Zilli, Mondher Kortas, Mohamed Habib Grissa, Ismail Elalamy, Wahid Bouida M and Semir Nouira
  
  Enoxaparin is a complex, biologically derived low-molecular-weight heparin. The manufacturing process for biologics is complex which makes difficult to obtain exact replicas of the reference biologic. This is why there is a critical need to ensure that generics of biologic medicines are safe and effective. This study was carried out to assess the comparability of a Tunisian generic enoxaparin (Enoxamed®, Unimed Laboratory, Tunisia) with the originator product (Lovenox®; Sanofi US, Bridgewater, New Jersey) through non-clinical in vitro study in healthy volunteers and clinical studies (phases III and IV) in patients with acute coronary syndrome (ACS). For non-clinical study, blood from healthy volunteers was used to compare the effect of both formulations using anti-Xa activity and the thrombin generation test (TGT). All parameters of TGT were analyzed. For clinical studies, ACS.. View More»
  DOI: 10.4172/jbb.1000304

  Abstract PDF