To the group:Back to the Top
I would like to know if there is any internationalregulation regarding
(I couldn't find any) "How long serum/plasma samples of a BE study
should be kept after it has been completed and the Test product
declared bioequivalent (by the corresponding national sanitary
Dear Silvia GiarcovichBack to the Top
I have just seen following and mayhelp you .Please confirm and
let every one know thedetails,
In a Federal Register notice of May 26, 2004, the Food and Drug
Administration (FDA) announced the availability of a guidance for
entitled "Handling and Retention of BA and BE Testing Samples." The
is intended to provide recommendations for study sponsors and/or drug
manufacturers, contract research organizations, site management
organizations, clinical investigators, and independent third parties on
procedure for handling reserve samples from bioavailability (BA) and
bioequivalence (BE) studies. The guidance clarifies how to distribute
articles and reference standards to testing facilities, how to randomly
select reserve samples, and how to retain reserve samples.
Dear Silvia,Back to the Top
The guidance referred to by Dr. Kurani is indeed applicable for final
studies for submission in USA and should be taken into consideration
you plan to submit in USA. The testing samples mentioned in the title,
however, refer to the medication that was used in these studies.
As far as I know, this guidance is not applicable for storage of
Office *: +32 1460 6175
Mobile *: +32 473 900207
Dear Dr. Kurani:Back to the Top
Thanks a lot for your prompt response. However, I think that the
you suggest refers to the test and reference formulations and I am
particularly asking about the plasma/serum samples.
Thanks again, Silvia
@ SilviaBack to the Top
I don't know of any national or international guideline covering this
Our procedure (we are a CRO) is to store all biosamples until half a
year after acceptance of the report by the sponsor.
After that time we ask the sponsor if he agrees in the destruction of
samples. If not, we simple charge for additional storage.
After destruction of the main batch we keep a representative number of
samples chosen at random form the study\0xEDs subjects (e.g., for a 2x2
cross-over in 24 subjects we keep samples from 2 subjects, entire
profiles - test and reference).
@ Dr Kurani
The drafted FDA guideline deals with the storage of test and reference
*preparations* in BE studies, not biosamples.
Helmut Sch\0xB8tz Biokinet GmbH / Dept Biostatistics
Neubaugasse 36/11 Nattergasse 4
A-1070 Vienna/Austria A-1170 Vienna/Austria
tel/fax +43 1 9713935 tel +43 1 4856969 62
no cell phone ;-) fax +43 1 4856969 90
Hi all,Back to the Top
Is there any chance that FDA might ask for the samples if they audit
the CRO before the approval of the Regulatory Submission(ANDA)
Hi Vardhini,Back to the Top
No, FDA doesn't look for the retention of plasma samples used in the
Since they come for an audit after 6 months- 2 yrs post study, they
expect the sponsors or CRO to store the plasma samples.
Retention is applicable only to the drug products used in the BE study
an ANDA/ NDA application.
Ranbaxy Clinical Pharmacology Unit
Ranbaxy Laboratories Limited, New Delhi, India
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