Bioequivalence and Bioavailability Forum 09:33 CEST

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

PK parameters [NCA / SHAM]

posted by lakshmiprasad - India, 2018-05-17 06:55  - Posting: # 18771
Views: 617

Hi

good morning to all,


I would like to know about the PK parameters with respective to elimination rate constant.


generally Kel will use as a secondary parameter in PK analysis.


one of regulatory audit (FDA) suggested that, u need to perform the Kel lower and Kel upper. Thereafter we are keeping the Kel lower and Kel upper parameter in the protocol as well as performing the PK analysis for the both parameters.

Now My concern is, what is the technical reason behind the Kel Lower and Kel upper. it was mandatory to keep the Kel lower and Kel upper in the protocol and PK analysis.


Please guide me on above mentioned.


Edit: Category changed; see also this post #1. [Helmut]

Complete thread:

Back to the forum Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
18,761 posts in 3,996 threads, 1,264 registered users;
online 24 (0 registered, 24 guests [including 12 identified bots]).

The purpose of models is not to fit the data,
but to sharpen the questions.    Samuel Karlin

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed