
- 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
Articles in this issue
over 10 years ago
FDA Seeks Resources to Support New Research Initiativesover 10 years ago
Safety Considerations for Follow-On Non-Biologic Complex Drugsover 10 years ago
Putting the EMA House in Orderover 10 years ago
Experts Call for Urgent Action on Antibiotics Researchover 10 years ago
Oncology Leads Personalized Medicineover 10 years ago
Characterizing the Real Cost of Site Regulatory Complianceover 10 years ago
Using 505(b)(2) to Solve Shortfall from Generic Cliffover 10 years ago
Lifecycle Modeling and Simulation in Clinical Trialsover 10 years ago
The U.S. Biosimilar Pathway: Policy Precedes Scienceover 10 years ago
Managing Portfolios for Economic and Clinical ValueNewsletter
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