Applied Clinical Trials Digital Edition - June/July 2015

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Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-06-01-2015, Volume 24, Issue 6

Regulatory: Solving Generic Cliff with 505(b)(2) The U.S. Biosimilar Pathway Trial Design: Modeling & Simulation Strategies Lifecycle Management: Bridging Economic & Clinical Value Also in this issue: EMA's Dueling Tones on Regulatory Vision Regulatory Compliance: The Site Burden Assessing Safety for Follow-on NBCDs