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Dear sir,
Is it compulsory to submit Investigator's brochure for BA-BE studies
by sponsor?
How many half lifes should be included in Phlebotomy schedule or time
points of study and between two washout periods?
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The following message was posted to: PharmPK
Dear Santhosh
Investigator's Brochure is meant for NCE's or IND's
only. For BA-BE studies, a product monograph of the
innovator appended to the study protocol will suffice.
You need to collect blood samples for atleast 3 to 5
half-lives. If half life is very high, as per USFDA a
truncated schedule upto 72 hours will be sufficient.
As per USFDA, a washout of 5 half lives is sufficient
to avoid predose concentration which is more than 5%
of Cmax.
It is advisable to have atleast 7-10 half lives as
washout period.
V. Rajesh
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The following message was posted to: PharmPK
Dear Santesh!
In the European Union an Investigator's Brochure is mandatory for ALL
clinical studies - and IMHO as well in countries implementing GCP
according to ICH E6.
If a product is registered within the European Union, the SmPC
(Summary of Product Characteristics) may replace the also mandatory
IMPD (Investigational Medicinal Product Dossier).
If a procuct is registered in a non-EU country which has concluded a
'Mutual Recognition Agreement' about GMP with the EU ('MRA-country' =
Australia, Canada, Japan, New Zealand, Switzerland, USA: http://
www.emea.eu.int/Inspections/MRACH.html) the SmPC may also replace the
IMPD, if the product is analysed according to current standards and
released for the study by the 'Qualified Person' of the sponsor.
.-a-. V. Rajesh
You wrote 'Investigator's Brochure is meant for NCE's or IND's only.
For BA-BE studies, a product monograph of the innovator appended to
the study protocol will suffice.'
If you you make such a general statement (which does not hold for the
EU), please state the legislation you are referring to ;-)
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://
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