Applied Clinical Trials Digital Edition - June/July 2015
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
Articles in this issue
FDA Seeks Resources to Support New Research Initiatives
Safety Considerations for Follow-On Non-Biologic Complex Drugs
Putting the EMA House in Order
Experts Call for Urgent Action on Antibiotics Research
Oncology Leads Personalized Medicine
Characterizing the Real Cost of Site Regulatory Compliance
Using 505(b)(2) to Solve Shortfall from Generic Cliff
Lifecycle Modeling and Simulation in Clinical Trials
The U.S. Biosimilar Pathway: Policy Precedes Science
Managing Portfolios for Economic and Clinical Value
Applied Clinical Trials Digital Edition - June/July 2015
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