Comparing the biological impact of glatiramer acetate with the biological impact of a generic.

ABSTRACT: For decades, policies regarding generic medicines have sought to provide patients with economical access to safe and effective drugs, while encouraging the development of new therapies. This balance is becoming more challenging for physicians and regulators as biologics and non-biological complex drugs (NBCDs) such as glatiramer acetate demonstrate remarkable efficacy, because generics for these medicines are more difficult to assess. We sought to develop computational methods that use transcriptional profiles to compare branded medicines to generics, robustly characterizing differences in biological impact. We combined multiple computational methods to determine whether differentially expressed genes result from random variation, or point to consistent differences in biological impact of

ORGANISM(S): Mus musculus

SUBMITTER: Tal Hasson 

PROVIDER: E-GEOD-61901 | biostudies-arrayexpress |

REPOSITORIES: biostudies-arrayexpress