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Hello.
I am assisting a physician researcher who wants to investigate the effects of a drug cocktail. The agents are mostly marketed (not for the indication in the study) but one is under clinical trials and a few are not commercially available as injectable forms. The mixture will be administered via IV infusion. The team has positive animal efficacy data and needs to obtain non-clinical data for an IND. The goal is to improve patient outcome, not commercialization, at this point.
I have provided a few feasible options, including investigating only those available as injectable forms. I was wondering if anyone could provide any insights or suggestions for:
- Are there any regulatory precedents of drug cocktails of more than four chemical drugs?
- When mixing only marketed drugs for immediate IV infusion, what would be the scope of non-clinical safety data and stability data required for an IND?
Any other guidance would be appreciated. Thank you.