PharmPK Discussion - Population pharmacokinetic studies mandatory in EU.

PharmPK Discussion List Archive Index page

On 10 Dec 1999 at 20:50:48, (emasson.-at-.ANAPHARM.com) sent the message


I heard that population PK or PD studies will be mandatory for registration
in Europe by 2003.  Can anyone confirm this, and indicate where we can find
confirmation of this.  I have looked on the web site of the EMEA but found
no document to confirm that.

Thanks,

Eric Masson, Pharm.D.
Scientific Director,
Anapharm inc
2050, boul Rene-Levesque West,
Ste-Foy, QC, Canada, G1V-2K8
418-527-4000 (EXT:222)
FAX: 418-527-3456

Back to the Top

On 12 Dec 1999 at 21:41:12, Mats Karlsson (Mats.Karlsson.-a-.biof.uu.se) sent the message


Dear Eric and others

In my dreams PK/PD studies are a mandatory part of the European
submission
package.  In reality, this is not the case and there is no documentation
in
existence, or in preparation, that would make it mandatory.  What I have
managed to put in place is that PK/PD information, if it is provided,
should
also be included in the SmPC (European Drug Label).  There are a couple
of
other European regulatory documents being prepared that also make
mention of
PK/PD, but these are not final yet.

As a plea from a regulator who believes that PK/PD information is almost
vital
in some submissions, and that the lack of it means the implications of
changes
in PK cannot be properly assessed, I would ask that this kind of
information be
included in the submission package whether it is a mandatory requirement
or
not.

Kind regards

Janet

(Janet R. Wade
Medical Products Agency, Sweden)

Back to the Top

On 21 Dec 1999 at 13:50:47, "Ronald Kavanagh 301-827-6408 FAX 301-443-9282" (KAVANAGHR.at.cder.fda.gov) sent the message


I have to agree with Janet. I've seen a number of situations were PK/PD
could save a drug.

In addition to dose selection, this is especially common with
supplemental applications where a new formulation is bioinequivalent
(esp. pharmaceutical alternatives).

PK/PD data, even if generated during the original marketing application
can show that differences in bioavailability are not expected to be
clinically significant. Alternatively if PK/PD data do indicate a
clinical difference they can help to justify a different dose with the
alternative formulation, or it may result in approval with slightly
different labeling.

Without PK/PD data there would be no basis to justify an approval.

The above is my personal opinion and does not necessarily reflect the
views of the FDA.

Ron Kavanagh
Food & Drug Administration, FDA

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 pharmacokinetic studies mandatory in EU." as the subject

PharmPK Discussion List Archive Index page