|Articles|June 1, 2015

Applied Clinical Trials

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

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
External Link - 2015-06ACT.pdf

Articles in this issue

over 10 years ago

FDA Seeks Resources to Support New Research Initiatives

over 10 years ago

Safety Considerations for Follow-On Non-Biologic Complex Drugs

over 10 years ago

Putting the EMA House in Order

over 10 years ago

Experts Call for Urgent Action on Antibiotics Research

over 10 years ago

Oncology Leads Personalized Medicine

over 10 years ago

Characterizing the Real Cost of Site Regulatory Compliance

over 10 years ago

Using 505(b)(2) to Solve Shortfall from Generic Cliff

over 10 years ago

Lifecycle Modeling and Simulation in Clinical Trials

over 10 years ago

The U.S. Biosimilar Pathway: Policy Precedes Science

over 10 years ago

Managing Portfolios for Economic and Clinical Value

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