PK of new molecules [Design Issues]

posted by nobody – 2017-04-18 16:19 (2853 d 01:40 ago) – Posting: # 17247
Views: 4,150

Hi!

What are we talking about? First-in-man? Mass balance? Dose-escalation in healthy volunteers?

If you have no experience (especially with the allometric scaling for first dose and necessary in vitro studies for tox/safety pharmacology/pk/metabolism) I would not even think about designing such trials based on "internet knowledge". Humans are not rats and rabbits.

Kindest regards, nobody

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