On 15 October 2011, the Pharm. D. Program at BZU held a seminar entitled: “Generic Drug Development and Technology Transfer,” led by Dr. Hani Shtayya. The seminar discussed the main principles and stages involved in the development of a generic drug and scale up of the various steps to production.

A summary of the stages discussed included: Pre-formulation studies, active sourcing and evaluation, formulation development including choice of excipients, small and scale up trial batches, process qualification, pivotal production, process optimization, stability studies and bioequivalent studies followed by final scale up to production levels.