Clinical Trials

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Browsing Clinical Trials by Author "Belete, Anteneh(Dr. )"

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    Challenges and prospects of the regional bioequivalence center initiative in Ethiopia: a qualitative study.
    (Addis Abeba University, 2020-10) Melesse, Yajeb; Hailu, Asrat (Prof, ); Belete, Anteneh(Dr. )
    Background: Evaluation of the interchangeability of multi-source generic drug products or bioequivalence study has become a crucial activity since the share of generic medicines in healthcare has enormously grown over the past few decades. Among four East African Countries, namely, Ethiopia, Kenya, Uganda and Tanzania, there has been an initiative to establish an accessible and affordable BE center for the regional pharmaceutical manufacturers. This study aims at assessing the challenges and prospects of the bioequivalence center initiative in Ethiopia. Methods: In-depth interview was conducted with individuals who were Ethiopian affiliates of the Regional Bioequivalence initiative; local pharmaceutical manufacturers, Ethiopian Food and Drug Administration, Regional Bioequivalence Center and other key stakeholders who are involved in the center capacity building. Data were collected using digital voice recorders, and transcribed. These data were analyzed using an inductive thematic analysis using Nvivo software and the findings were presented in narratives using the respondent‟s own words as illustrations. Results: Based on the findings, four major themes, one as an opportunity and three as challenges, were identified. The mere presence of the Regional Bioequivalence Center by itself was considered as an opportunity by most of the participants. In addition, a number of favorable conditions including awareness and demand for product quality and diversity, the presence of attractive incentive packages for local pharmaceutical manufacturers and the proliferation of the generic medicines market in the region were mentioned as opportunities. On the other hand, lack of resources and stakeholders‟ commitment as well as lack of regulatory enforcement were identified as challenges. Conclusions: The Bioequivalence center initiative has not functioned well as initially planned. The findings of this study suggest the need for government and key stakeholders to actively engage in the program to make the initiative viable. The significance of supporting this initiative could positively contribute to the creation of a competitive local manufacturing sector that will engage in the production of therapeutically interchangeable generic products and ultimately safeguard the health of the society at large.