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Development of Bio Equivalency Studies in Armenia
Project Cost:
$ 4,600,000
Internal rate of return (IRR) -
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PROJECT DESCRIPTION
Investment Plan (1)
Disclaimer
The project is about the establishment of a complex which will enable to conduct bio equivalence studies for generic drugs.Drug producers need to get the evidence of compliance of generic drug to brand one. The only way to prove it is bio equivalence study results. Drug registration bodies in all countries require Dossiers, as an evidence that this generic drug is equivalent to brand one. It is impossible to register generics without Dossiers.Bio equivalence study will assure that new generic is safe, efficient and corresponds to quality requirements.The project implementation will involve:
• Clinic for volunteers /for in vivo studies,
• Analytical laboratory /for blood sample analyses,
• R&D department /for project management, statistical analyses, report writing and Dossiers design.
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