Bioequivalence and Bioavailability Forum

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log-in |  Register |  Search

Back to the forum  Query: 2017-04-24 13:25 CEST (UTC+2h)
 
BE-proff
Senior

Russia,
2017-04-18 06:25

Posting: # 17244
Views: 322
 

 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: 271
 

 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: 255
 

 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: 221
 

 PK of new molecules

Hi nobody,

I was talking about First-in-man studies (healthy volunteers).
Back to the forum Activity
 Thread view
Bioequivalence and Bioavailability Forum | Admin contact
16,763 Posts in 3,598 Threads, 1,038 registered users;
17 users online (0 registered, 17 guests).

Exploratory analysis: The art of finding a Rembrandt
in a Jackson Pollock.    Stephen Senn

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
XHTML/CSS RSS Feed