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Assessing Abuse Potential of CNS-Active Compounds: Regulatory Environment & Challenges
Learn about the regulatory environment for the assessment of abuse potential of CNS-active drugs, explore the importance of early vetting of abuse potential and identify critical steps in your regulatory strategy.
As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents? Continue reading →