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RegisterPK of new molecules [Design Issues]
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.
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
Kindest regards, nobody
Complete thread:
- PK of new molecules BE-proff 2017-04-18 06:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- PK of new molecules DavidManteigas 2017-04-18 11:58
- PK of new moleculesnobody 2017-04-18 14:19
- PK of new molecules BE-proff 2017-04-19 08:35
- PK of new molecules nobody 2017-04-25 09:17
- PK of new molecules BE-proff 2017-04-19 08:35
Ing. Helmut Schütz