Guideline on the conduct of bioequivalence studies for veterinary medicinal products
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The revised EMA guideline for the investigation of bioequivalence for immediate release oral formulations with systemic action.
On August 1, 2010, a revised guidance regarding bioequivalence (BE) assessment for the approval of innovator (bridging studies, variations, line extensions) and generic medicinal products in the EU came into effect (EMA Guideline on the Investigation of Bioequivalence, CPMP/EWP/QWP/1401/98 Rev. 1/Corr**, London, 20 January 2010). This guideline specifies the requirements for BE assessment for i...
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Additional Notes This note for guidance concerns the application of Part 4, section E of the Annex to Directive 75/318/EEC as amended and Article 4,2 point 8 of Directive 65/65/EEC as amended with a view to the granting of a marketing authorisation for a medicinal product. It defines when bioavailability or bioequivalence studies are necessary for immediate release products with a systemic effe...
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Two product types used to rllustrate the problems The Europcan Community (EC) Committee for Veterinary Medicinal Products (CVMF) has recently adopted a guideline for in-use (open-bottle) stability testing1. There is no equivalent document offering guidance in the European (i.e. the EC and EEA) human medicinal product sector. However, several Committee for Proprietaly Medicinal Products (CPMP)/C...
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Two drug products are considered bioequivalent 'if their bio-availabilities ... are similar to such a degree that their effects, with respect to both efficacy and safety, will essentially be the same'. 1 The bioequivalence of two drug products is generally demonstrated through a clinical study in healthy volunteers, the so-called bioequivalence study. If bioequivalence is shown for two drug pro...
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تاریخ انتشار 2011