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21 04, 2014

Conducting BA/BE Studies in The Middle East and North Africa (MENA)

By | 2016-10-12T14:35:11+00:00 April 21st, 2014|Categories: News|Tags: , , , , , , , , , , , |

Bioavailability (BA) and Bioequivalence (BE) studies are important for both marketing generic products and developing a new chemical entity.  For the former, these are the quintessential studies required for approval.  The potential to-be-marketed generic product (test product) is examined against a commercially-available brand product (reference product) under the same molar dose and under similar conditions to confirm that the mean plasma concentration over time is comparable.  Key pharmacokinetic parameters examined [...]