Back to the Top
Dear all,
Does someone have an idea if non GLP studies for Phase I clinical
sample assays are acceptable for regulatory authorythies such as FDA
or EMEA? Can I find this information on internet?
Thanks a lot in advance.
Dr. L. Monlauzeur
Back to the Top
I'm not sure if I understand your question.
In general, regulatory authorities expect preclinical animal studies
to be conducted to GLP standards in order to dose humans with a new
experimental drug in Phase 1. Samples collected from preclinical
animal studies need to be analyzed by validated methods (for samples
analyzed by bioanalytical methods, see FDA Guidance for Industry
Bioanalytical Method Validation; http://www.fda.gov/cder/guidance/
4252fnl.pdf). It is up to you to determine the detail and extent of
the validation to conduct for a particular method, but you will need
to defend what you did to regulatory authorities in order to proceed
to human dosing.
Samples collected from human studies are generally expected to be
analyzed by equivalently validated bioanalytical methods.
If I misunderstood the question, please let me know.
Tom Tarnowski
Thomas Tarnowski, Ph.D.
ttarnowski1.aaa.aol.com
Back to the Top
The following message was posted to: PharmPK
Dear Dr. Monlauzeur!
EMEA states in their BA/BE-Guideline
http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf
at "3.4 Chemical analysis":
"The bioanalytical part of bioequivalence trials should
be conducted according to the applicable principles
of Good Laboratory Practice (GLP).
best regards,
Helmut
--
Helmut Schuetz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna/Austria
tel/fax +43 1 2311746
http://BEBAC.at
Bioequivalence/Bioavailability Forum at http://forum.bebac.at http://
www.goldmark.org/netrants/no-word/attach.html
Back to the Top
Dear All,
FDA has issued a draft guidance in Jan 2006 on this
subject. FDA is considering implementing all or few of these
recommendations as direct rule in Federal register by June 2006.As per
this proposal, requirements for Clinical Phase I studies will have some
exemptions to CFR Part Part
211.
http://www.fda.gov/cder/guidance/6164dft.htm
As far as level
of validation required for analytical method used for charcterization
and testing of drug products and raw material for Clinical Phase I is
concerned,issue has been discussed many times and outcome is :
practically you don't need to have fully validated analytical method at
this stage of clinical development and all you need is some analytical
verification work to establish factors like linerity, sensitivity,
accuracy etc to prove that the method we have is a working
method.
Typically,we don't have final product/ product strength at
clinical Phase I stage, so there is no question of doing full analytical
method validation at this stage.This is typically done in early clinical
Phase III.
I will appreciate comments from group on this
matter,
Thanks,
Pradeep BHadauria
Lead Scientist
Cardinal Health
Inc.
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)