Nonclinical Studies in Cell/Gene Therapy: Key Considerations & Regulatory Guidance
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In this scientific publication, we review considerations for nonclinical cell and gene therapy development, including expert approaches to mitigating complex challenges, improving study efficiency, and maximizing translational opportunities from nonclinical to first-in-human trials.
November 3, 2024
Learn about:
• The ICH S-12 Guideline on nonclinical biodistribution studies
• Species selection criteria per the FDA
• Choosing the appropriate vector
• Immunogenicity evaluations
• Findings from two case studies
Dive in for a wealth of knowledge!
Published: November 3, 2024