Dear all, Is there any regulatory requirements for weight range and ageBack to the Top
for rat and mice in pharmacokinetic studies? Can we use adult rats
350-400 g (approx age 12-16 weeks) for PK studies. Generally most PK
studies use 250-300 g rats. Did any one found the difference in blood
levels? Thanks in advance, Jagdish Jagdish K. Jaiswal, Ph.D. Research
Associate Drug Discovery (Pharmacology) Torrent Research Centre India
Dear Jagdish,Back to the Top
There are no regulatory guidelines for weight range of rats and mice in
PK studies. Generally people prefers to use the animals of same weight
range which are being used in efficacy studies to rationally support efficacy
studies. But for understanding purpose, you can do the PK study in different weight range of animal in both species in order to understand the
impact of age on ADME. In our in-house studies in rat, we use young animals about 200-220 g in weight for PK studies but we also have the data for 300-320 g weight of animals. PK parameters were found to be different in different age of
animals.
Metabolic profile and clearance may change in different age group of animals. This may give different systemic exposure with specific to age group.
Vinod Patil,
Wockhardt Research Centre, Aurangabad
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)