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Apples and Oranges,- Case Studies on Similarity, Comparability and Equivalence Regarding Potency Determination
Speaker Presentation Beck Hermann F. Hoffmann-La Roche Ltd. 2024
Workshop Introduction to Bioassay Development
Speaker Presentation Workshop Introduction to Bioassay Development
Utilizing HiBiT TCK Bioassays To Validate Cell Therapy & mAb-Mediated Immunotherapy Potency
Speaker Presentation Hess Nicholas Promega Corporation 2024
Adapting CMC Bioassay Strategies in Response to an Evolving ADC Pipeline
Speaker Presentation Hussman Patrick AstraZeneca 2024
Bioassays 2024 Scientific Program
Scientific Program: Bioassays 2024
Bioassays 2024 Summary Infographic
Summary Infographic: Bioassays 2024
When Simulation is Not Enough - When and Why Are Real World Studies of Shipping Needed
Roundtable 8 Notes: WCBP 2024
Visible and Sub-visible Particles - New Approaches and Requirements
Roundtable 18 Notes: WCBP 2024
Unlocking the Genetic Code - NGS Marvels in the Realm of Cell Therapy
Roundtable 21 Notes: WCBP 2024
Technical Transfer of Analytical Procedures - Approaches for Streamlining and Discussion of Regulatory Submissions Experiences
Roundtable 10 Notes: WCBP 2024
Supply Issues of New Medicines – Focus on Equitable Access in Third World Countries
Roundtable 12 Notes: WCBP 2024
Setting Specifications on Limited Data, Clinically Relevant Specs - Next Generation Control Strategies - Looking Ahead to Revision of ICH Q6B
Roundtable 1 Notes: WCBP 2024
Setting Specifications on Limited Data Clinically Relevant Specs - Next Generation Control Strategies - Looking Ahead to Revision of ICH Q6B - What is Needed
Roundtable 1 Notes: WCBP 2024
Role of Cryo-TEM as an Orthogonal Method to Help Assess Formulation Purity, Potency for Nanoparticles
Roundtable 16 Notes: WCBP 2024
Regulatory Expectations and Challenges: Lessons Learned from Developing Countries
Roundtable 12 Notes: WCBP 2024
Regulatory Considerations and Experiences for Control Strategies in Different Regions - Focus on General Challenges with Divergence
Roundtable 6 Notes: WCBP 2024
Regulatory Considerations and Experiences for Control Strategies in Different Regions
Roundtable 6 Notes: WCBP 2024
Regulator Review Preferences and Recent Review Trends: Questions and Key Issues - Focus on US FDA
Roundtable 4 Notes: WCBP 2024
Regulator Review Preferences and Recent Review Trends - Questions and Key Issues - Focus on Ex-US Regions
Roundtable 4 Notes: WCBP 2024
Recent Experiences with Regulation of Biosimilars at the FDA
Roundtable 15 Notes: WCBP 2024