News & Views

IT Solutions Focus

Oct 26 2007

Author: Kim Shah, Thermo Fisher Scientific and Ajit Nagral, Megaware Inc. on behalf of Unassigned Independent Article

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Rapid market growth in generic drug manufacture is driving the requirement for fast efficient bioequivalence studies to meet FDA ANDA (Abbreviated New Drug Application) guidelines. Bioequivalence studies are a critical component of ANDA submissions. The purpose of these studies is to demonstrate pharmaceutical equivalence between a generic drug product and the corresponding reference listed drug. Establishing bioequivalence allows for a regulatory conclusion of therapeutic equivalence [1]. According to IMS Health, global generics sales are increasing by 19% per year [2]. A generic is the bioequivalent of an original pharmaceutical product, whose patent has expired. Generics are much cheaper to produce than the original brand on which they are based. Once a product has lost patent protection, it is replaced almost entirely within six to twelve months by generics, which are sold at 85% to 90% less than the original products [3]. This compression of the time-to-market for generics, and the extreme price sensitivity of final generic drugs means that speed and cost are major drivers for customers. The urgency to remove stages from the manufacturing process of generic drugs is more compelling than ever in order to ensure improved throughput and much easier regulatory compliance.

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