PharmPK Discussion - Non compartmental, compartmental, population analysis comparisons

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On 15 Mar 2000 at 21:11:02, Shiva Patil (patils.-at-.knoll-pharma.com) sent the message


Hi:

Could I get some information on reference studies where
non-compartmental/compartmental and population approaches are validated for the
analysis of PK data on one or two drugs?

Thanks,

-Shiva

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On 19 Mar 2000 at 20:40:54, "Jogarao Gobburu 301-594-5354 FAX 301-480-3212" (GOBBURUJ.at.cder.fda.gov) sent the message


Hello,
   I am not sure I fully understand the question. Perhaps, you mean
non-compartmental/compartmental MODEL validation. Validation may be too
strong a word and other terms like evaluation or checking should be
considered. We do not have a well-accepted terminology yet.
   Model evaluation should be specific. We need to clearly state the
objective of modelling given data (eg: I want my model to predict AUC(0
- infinity), disease status at the end of 1 yr, etc..). Model developed
for one purpose may not be suitable for another purpose. A linear model
may be suitable for 'describing' a concentration-effect relationship. It
may not be suitable for, say, extrapolation to higher concs. I would
encourage you to look at the population PK guidance at:
  http://www.fda.gov/cder/guidance/index.htm
The guidance discusses various methods to evaluate or check model
performance. (For now the guidance uses the term 'validation'). It
should be of help.

Regards,
  Joga

Joga Gobburu
Pharmacometrics,
CDER, FDA.

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