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Back to the forum  Query: 2017-09-21 23:19 CEST (UTC+2h)
 
BE-proff
Senior

Russia,
2017-04-18 06:25

Posting: # 17244
Views: 1,053
 

 PK of new molecules [Design Issues]

Hi All,

Let's say I have developed a new molecule and I want to study its PK in humans :-D
Can anybody recommend a manual (available on the Internet at no charge) for such studies? :confused:
DavidManteigas
Regular

Portugal,
2017-04-18 11:58

@ BE-proff
Posting: # 17246
Views: 908
 

 PK of new molecules

Hi BE-proff,

Can anybody recommend a manual (available on the Internet at no charge) for such studies?

The only ones I know are guidelines. All the others are paid.

If you are looking for paid alternatives, there are a lot of specific literature on the subject, mainly for adaptive oncology clinical trials.
nobody
Senior

2017-04-18 14:19

@ BE-proff
Posting: # 17247
Views: 891
 

 PK of new molecules

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
BE-proff
Senior

Russia,
2017-04-19 08:35

@ nobody
Posting: # 17251
Views: 853
 

 PK of new molecules

Hi nobody,

I was talking about First-in-man studies (healthy volunteers).
nobody
Senior

2017-04-25 09:17

@ BE-proff
Posting: # 17261
Views: 633
 

 PK of new molecules

Hi!

Here some appetizer

http://www.clinbay.com/download/Presentations/2013-04-11_Phase_1_WS_Adaptive_Design.pdf


...but again: Don't do that at home. It's a complex, multidisciplinary process requiring much, much experience from preclinical and clincal (pharmacology) department ;-)

Kindest regards, nobody
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