Back to the Top
The following message was posted to: PharmPK
The Clinical Pharmacokinetic and Clinical Pharmacology Community:
I'm looking for a little help/consensus regarding PK in ICH CSR's.
experience you could share regarding the following two items would be
1) As best as I can tell, the ICH format for a CSR does not have
headers or subheaders for pharmacokinetic methods, results or
I would be very interested in knowing under which ICH section numbers
titles authors have been placing these pharmacokinetic sections.
2) I am also interested in how people have been presenting the
subjects' plasma drug concentrations and individual subjects'
pharmacokinetic parameters in an ICH CSR. I'm accustom to a format
the individual subject values appear on the same table as the summary
statistics such as mean, median %CV, etc, so the reader can see what
individual values go into a particular summary statistic all in one
In other words, that which ICH might refer to as a listing and that
referred to as a table both appear on one page as a table in the table
section (the way WinNonlin table maker might create it). Is this what
others are doing? If so, do you make any entry in the "listing" part
CSR directing attention to the table?
Thank you for your time and assistance.
Back to the Top
re: I'm looking for a little help/consensus regarding PK in ICH
ICH-3 was developed for Phase III studies and as such does not 'work'
for studies in which you have complete profiles The only place where
ICH-3 mentions PK is in section 16.2.9 I think.
We have chosen to simply add PK sections in the CSR, either before or
after the sections on safety, which describe materials and methods,
stats and results, also in the Synopsis. Our tables usually present
individual and mean PK parameters and these would go in Section 14
somewhere (replacing efficacy sections) only if the Sponsor insists
on keeping the numbering of the ICH 3 index (which is not a template,
it is just an index of that document), together with plots of mean
concentrations and scatters to examine dose proportionality or dose
linearity. The individual plasma/urine concentrations go in Section
16, with plots of individual concentrations, again only if the Sponsor
is adamant about the numbering.
Our preference is to have an Appendix A for study documentation, B for
Tables and graphical presentations of mean data and an Appendix C for
listings and plots of individual data. The appendices follow the way
the data/items/variables are grouped in ICH-3 but any level/item that
is not applicable for our type of study is left out.
For you interest maybe, one of the persons on the Committee who
developed the ICH-3 guidelines published an article some years ago in
the quarterly magazine of the European Medical Writers Association,
expressing his amazement at the fact that the index of the guideline
was now being used as a template and particularly, that industries
used this index also for CSRs of Phase I studies, for which it is not
suitable at all. And everyone was encouraged to develop their own
template, based on the those items a Regulatory Authority would expect
to see in a report of a study at that particular stage of development.
For most of our Phase I CSRs we use our own template.
Kendle International B.V.
3584 CJ Utrecht
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 "Pharmacokinetics in an CSR using ICH format" as the subject
Support PharmPK by using the
Copyright 1995-2011 David W. A. Bourne (firstname.lastname@example.org)