Premarket safety population size associated with approval of expedited program drugs and orphan drugs.
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DOI: 10.1016/j.jclinepi.2019.04.021
Abstract: OBJECTIVE For approved expedited program and orphan drugs, the safety populations used for premarket drug risk assessments are often limited in size. The study's objective was to determine whether large safety populations, with the capacity… read more here.
Keywords: expedited program; safety populations; safety; orphan drugs ... See more keywords