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Back to the forum  2018-06-18 13:57 CEST (UTC+2h)

PK of new molecules [Design Issues]

posted by nobody - 2017-04-18 14:19  - Posting: # 17247
Views: 1,669

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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