Specification Setting for Biopharmaceuticals: Expert Panel Discussion on Best Practices
Expert Insight & Answers
Patient-Centric Specification Setting: Beyond Batch Data
On-Demand Presentation by Dr. Simona Cianetti (GSK)
Statistically Sound Specification Setting – A Practical Approach Consistent with ICH Q6B and Q14
On-Demand Presentation by Dr Eric Rozet (GSK)
Regulatory science behind drug substance & drug product specifications of monoclonal antibodies
On-Demand Presentation by Dr. Patanachai “Kong” Limpikirati (Chulalongkorn University)
Setting Biopharmaceutical Specifications: Navigating Regulatory Requirements in Accordance with ICH Q6B
On-demand Presentation
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