Innovation Pharmaceuticals Inc (IPIX)

[TheHound]

FDA Guidance for Industry Antiviral Product Development — Conducting and Submitting Virology Studies to the Agency

SI mentioned on page 7.

“It is desirable to have a high therapeutic index giving maximum antiviral activity with minimal cell toxicity. We recommend determining CC50 values in both stationary and dividing cells from multiple relevant human cell types and tissues to ascertain the potential for cell-cycle, species, or tissue-specific toxicities. Studies determining cytotoxicity and therapeutic indexes should be conducted before the initiation of phase 1 clinical studies.”

https://www.fda.gov/media/71223/download