Journal of Bioequivalence & Bioavailability

Jean-Baptiste Nikiema

Publications

• Research Article
  Evaluation of the Bioequivalence Documentation Required For Registration of Generic Drug Products in Burkina Faso: Methodology of Implementation and Impact
  Author(s): Rasmané Semdé, Josias Bg Yameogo, Natacha L.S.M Toe Djiguemde, Roland Nao, Charlemagne Gnoula, Charles B Sombie and Jean-Baptiste NikiemaRasmané Semdé, Josias Bg Yameogo, Natacha L.S.M Toe Djiguemde, Roland Nao, Charlemagne Gnoula, Charles B Sombie and Jean-Baptiste Nikiema
  
  With a view to better warranty quality, efficacy and security of generic medicines, the national medicine regulatory authority (NMRA) of Burkina Faso has firstly evaluated in 2009, the country marketing authorization legal provisions and procedures. Then, a new procedure intended to enforce the technical evaluation of the registration applications has been adopted and progressively implemented during 2010 and 2011. This evaluation included the compliance of generic drugs to the quality and bioequivalence requirements. The results of the evaluations of the bioequivalence documentations provided in 2009, 2010 and 2011 for the registration of generic drugs were collected, analyzed and compared. Only the capsule and tablet oral dosage forms were considered in this study. The implementation of the new procedure did not discourage the applicants since the number of the drug registration app.. View More»
  DOI: 10.4172/jbb.1000126

  Abstract PDF