BE-proff
●    

2017-04-18 08:25
(2558 d 09:15 ago)

Posting: # 17244
Views: 4,238
 

 PK of new molecules [Design Issues]

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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
★    

Portugal,
2017-04-18 13:58
(2558 d 03:43 ago)

@ BE-proff
Posting: # 17246
Views: 3,574
 

 PK of new molecules

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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
nothing

2017-04-18 16:19
(2558 d 01:22 ago)

@ BE-proff
Posting: # 17247
Views: 3,664
 

 PK of new molecules

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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
●    

2017-04-19 10:35
(2557 d 07:05 ago)

@ nobody
Posting: # 17251
Views: 3,538
 

 PK of new molecules

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Hi nobody,

I was talking about First-in-man studies (healthy volunteers).
 
nobody
nothing

2017-04-25 11:17
(2551 d 06:23 ago)

@ BE-proff
Posting: # 17261
Views: 3,405
 

 PK of new molecules

Post reply
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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