PharmPK Discussion - Population PK/PD studies

PharmPK Discussion List Archive Index page

On 8 Oct 1998 at 10:54:34, "Eric Masson" (emasson.-at-.anapharm.com) sent the message


(This may be the second time for this message - db)

Would you consider conducting population PK/PD studies in phase III studies,
>for a biologic drug,  even if no PK studies have been done earlier during
>drug development (phase I-II) due to lack of assay? Because no data is
available, could extensive sampling be performed in a subset of subjects,
and sparse sampling in a larger cohort? What would be the
>advantage and disadvantage of using this approach to estimate PK/PD model,
>variability, and covariates in late drug development.

Back to the Top

Want to post a follow-up message on this topic? If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "Population PK/PD studies" as the subject

PharmPK Discussion List Archive Index page