Investigation to Explain Bioequivalence Failure in Pravastatin Immediate-Release Products

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...

Bioequivalence of Alprazolam Sublingual Tablet Formulation and Alprazolam Immediate Release Tablet in Healthy Volunteers

Alprazolam immediate release (IR) tablets are currently approved for the management of anxiety disorder or the short-term relief of symptoms of anxiety. A sublingual (SL) formulation of alprazolam, which disintegrates in the mouth without the need for additional fluids, has been developed. The aim of this study was to determine if the alprazolam SL 1 mg tablet was bioequivalent to the alprazola...

Formulation and bioequivalence of two Valsartan/Amlodipine immediate release tablets after a single oral administration.

The aim of this study was to formulate a film-coated Valsartan/Amlodipine (VS/AM) immediate release tablets and to evaluate their in vivo release profile. VS/AM core tablets were manufactured using dry granulation method. Opadry aqueous coating dispersion was used as film coating material. Dissolution of the film coated tablets was tested in 900 ml of 0.5% SLS media, bioequivalence of tablets w...

Investigation of Bioavailability and Bioequivalence

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...

Bioequivalence of Topical Dermatological Drug Products