Drug reformulations and repositioning in pharmaceutical industry and its impact on market access: reassessment of nomenclature.

ABSTRACT: Medicinal products that have been developed and approved for one disease may be the object of additional clinical development in other disease areas or of additional pharmaceutical development for new and different formulations. The newly developed products can be named as repositioned or reformulated products, respectively. Market access of repositioned or reformulated products in Europe and the United States is an interesting object of study as it may provide clarity about which parameters are assessed and considered to bring added value, other than the molecule itself. As such, we aim to evaluate if the added value of repositioned or reformulated medicinal products can be systematically described, quantified, and predicted. As a first step toward investigating the impact of market acces

SUBMITTER: Murteira S 

PROVIDER: S-EPMC4865745 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature