Resources
-
Understanding Mechanisms of Action and Structure‐Function Relationships: A Regulator’s Perspective
Speaker Presentation Shapiro Marjie CDER FDA 2018
-
Coagulation Factor Products: Potency Determination and Related Complications
Speaker Presentation Ovanesov Mikhail US FDA 2018
-
System and Sample Suitability Assessment for Potency Methods
Speaker Presentation Li Ruojia Bristol-Myers Squibb 2018
-
Successful Analyst Assay Training and Assay Transfers- Basics and Recommendations to Achieve These Goals
Speaker Presentation Knorre Alex Eurofins 2018
-
An MHRA Perspective on Bioassays
Speaker Presentation Both Leonard MHRA 2018
-
Minimization of Bioassay Test Result Shift When Implementing New Reference Standard Batches
Speaker Presentation Borer Matthew Eli Lilly 2018
-
Setting and Revision of Specifications - Regulatory Considerations/expectations; New Challenges, Interplay Between Analytical Test Results, Clinical Testing and Regulatory Expectations (Identification of CQAs)
Roundtable 6 Notes: AT Europe 2022
-
Why and How to Move New Analytical Technologies from R&D to GMP
Roundtable 5 Notes: AT Europe 2022
-
New Developments in Analytical Methods for Novel Modalities and PAT
Roundtable 4 Notes: AT Europe 2022
-
ICH Q2(R2) / ICH Q14
Roundtable 3 Notes: AT Europe 2022
-
Stability
Roundtable 2 Notes: AT Europe 2022
-
Vaccines – Analytical Platform Technology
Roundtable 1 Notes: AT Europe 2022
-
3D Structure of Biologics in a Convenient Immunoassay Format
Speaker Presentation Wang Xing Array Bridge 2017
-
Challenges with Equivalence Testing According to USP <1032>
Speaker Presentation Stegmann Ralf Stegmann Systems 2017
-
Bioassays in Product Development: An Immuno-Oncology Perspective
Speaker Presentation Stauffer Tara Bristol-Myers Squibb 2017
-
Setting up Acceptance Criteria with the Application of Equivalence Test and Geometric Mean Following USP Chapters -A Cell-based Potency Assay Case Study
Speaker Presentation Shi Liming Pfizer 2017
-
Comparative Analytical Method Transfer - Setting Acceptance Criteria
Speaker Presentation Rugaiganisa Andrew Pfizer 2017
-
Development of Generic Goal Posts for Equivalence Testing of Potency Assay Methods
Speaker Presentation Pflanzner Thorsten AbbVie 2017
-
Bioassay Method Transfer: Regulator’s Perspective and Case Studies
Speaker Presentation Nemec Martin Health Canada 2017
-
Antibody-Mediated Effector
Function: Learning and
Challenges from Early
Discovery to Development
Speaker Presentation Mehta Payal Eli Lilly & Company 2017