Bioequivalence and Bioavailability Forum

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]