The pivotal role of CMC in the drug approval process

Solid state chemistry, polymorphic forms of the drug and the ability to scale up manufacturing are very important details that define the identity as well as feasibility of a drug. Very minor changes in any or each of these aspects of the drug can pivot chances of scale up, or a process to launch or acquire approval. Things change on the brink of scale up and manufacturing for commercialization to almost derail approval and this talk will feature case studies in this area.

Event Location:
Zoom talk: https://us02web.zoom.us/j/88274227563