Please join us for an Open Scientific Discussion (OSD) hosted by the AAPS Translational and Clinical Sciences Community AAV Viral Shedding Working Group on viral shedding profiles of approved AAV gene ...

We can ask them, EP, and ICH. If there is consensus to develop this idea further, I suggest we get together to refine the concept. Rob

Good idea, Robert. Also, I wonder if the USP might be interested in developing online tools in this area. ------------------------------ Mark Powell PhD Director Mark Powell Scientific Limited NESTON ...

I have a suggestion. Many of us in this group face data uncertainty when preparing regulatory submissions. How about creating a mini course based on ICH and other sources identified during this conversation? ...

This is a good conversation; however, I would emphasize that the Context of Use (COU) needs to remain the central driver when considering validation expectations, particularly for multi-parameter biomarker ...