PharmPK Discussion - Population Analysis of Pooled Phase-I Data

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On 27 Apr 1998 at 13:57:27, "Jeffrey S. Barrett" (Jeffrey.S.Barrett.-a-.dupontmerck.com) sent the message


Question:

When conducting a population-based PK analyses of pooled phase-I studies
in a
model building setting, it should not be expected that the conclusions
of the
traditional non-compartmental analyses are exactly attained in the
population
setting.  Reasons for this include:
 - a data-rich setting most likely exists with the meta-analysis
of such data,
 - the conclusions drawn from the individual well-defined studies
may (or
          may not) have been drawn based on apriori designations of a
delta in
          effect (or comparable measure) and the sample size
requirements
          necessary to test this effect,
 - the covariates per study may be confounded based on the sites
chosen
          to enroll volunteers or patients or study design
characteristics.

Have I missed any potential reasons to explain this and what additional
NONMEM-specific reasons exist?  Are there advantages of FOCE over FO
methods in >this setting beyond the obvious?

Thanks,

Jeff Barrett, PhD
Principal Research Scientist
DuPont Merck

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