Metrics for absorption [NCA / SHAM]

posted by nobody – 2019-04-15 13:48  – Posting: # 20168
Views: 3,362

(edited by nobody on 2019-04-15 17:01)

» Hi nobody,

Ho Vienna


» If we have different metrics likely it would be better to chose one with high sensitivity.

Not more than needed. Over-discriminatory testing is a pain. I like the idea of "problem -> solution", not the other way around.

» IMHO, the clinical relevance of the rate of absorption is doubtful. Ask a clinician about Cmax and he will tell you that is important for safety,

Safety is part of clinics as well. If your patients die from toxicity or headache or bleeding or whatever you will learn the hard way.

» Remember that current regulatory thinking concentrates on the biopharmaceutical performance of the formulation in the first place. Mentioning clinical relevance outs you as a dinosaur of BE. :-D

Yeah, but in the end you are not interested in differences in "biopharm. performance" not reflecting any meaningful (= clinically relevant) differences between two formulations, or?

Kindest regards, nobody

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