North Africa

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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 [...]

15 04, 2014

Is Risk Based Monitoring Appropriate for MENA?

By | 2016-10-12T14:35:11+00:00 April 15th, 2014|Categories: News|Tags: , , , , , |

A recent article in the Journal of Clinical Studies Volume 6, issue 2, 2014* discussed the applicability of new FDA and EMA recommendations for risk-based monitoring. Knowing that greater than 30 per cent of a clinical budget is allocated to cover monitoring costs and more than 50 per cent of that is spent on source document verification (SDV), risk-based monitoring allows companies to more effectively target and prioritize resources around [...]