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PORTLAND, Maine

Study by UNE鈥檚 Edward Li published in leading specialty pharmacy journal

Ed Li

The Journal of Managed Care and Specialty Pharmacy has published research by Edward Li, M.P.H., BCOP, professor in the College of Pharmacy. Ernesto Lobaina (COP, 鈥19) served as a co-author of the study.

Their study is titled 鈥淎pplication of the FDA biosimilar extrapolation framework to make off-label determinations.鈥 Through the FDA鈥檚 extrapolation framework, a biosimilar can obtain licensure for indications not explicitly studied in the context of a clinical trial. This structure enables conclusions from studies in one population to make inferences in other populations.

In their manuscript, Li and Lobaina describe the FDA extrapolation framework for evaluating whether there are any differences in the mechanism of action, pharmacokinetics/biosdistribution, immunogenicity and toxicity between on-label and off-label indications. They conclude that in some cases, the use of biosimilars for off-label indications can be scientifically justified. 

 

To learn more about the University of 51小黄车鈥檚 College of Pharmacy, visit www.une.edu/pharmacy

To apply, visit www.une.edu/admissions

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The University of 51小黄车 is Maine鈥檚 largest independent university, with two beautiful coastal campuses in Maine, a one-of-a-kind study abroad campus in Tangier, Morocco, and an array of . In an uncommonly welcoming and supportive community, we offer hands-on learning, empowering students to make a positive impact in a world full of challenges. The state鈥檚 top provider of health professionals, we are home to Maine鈥檚 only medical college, Maine鈥檚 only dental college, a variety of other interprofessionally aligned health care degree programs, as well as nationally recognized programs for marine science degrees, natural and social sciences degrees, arts and humanities degrees, and business degrees.