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Title: Re: DDX and CTX
I thought that the major practical
significance of the DDX is that it is usable only for studies
involving drugs already marketed and approved in the country of the
trial. Thus it is relevant to extending usage of an approved
drug.
----- Original Message -----
From: Lassoff,
Peter
To: RegAffairs
Sent: Thursday, March 07, 2002 11:27
AM
Subject: RE: DDX and CTX
Dear Mr Grindel,
The DDX scheme is for prescribers who wish
to conduct clinical research independent of company involvement.
The CTX scheme is expected to be used by pharma companies wishing to
conduct clinical studies in the UK. It is dodgy for drug
companies to try to use the DDX scheme, then use the resulting data
for registration purposes. The DDX is quite a bit easier than
obtaining a CTX. If you require assistance with a CTX, please
let me know.
Kind Regards,
Peter Lassoff, Pharm.D.
Director, Europe North
Worldwide Regulatory Affairs
PAREXEL International Ltd.
River Court, 50 Oxford Road
Denham, Uxbridge, Middlesex
UB9 4DN, UK
Tel: +44 1895 614427
Fax: +44 1895 614375
Mobile: +44 7740 899 222
mailto:Peter.Lassoff@PAREXEL.com
http://www.PAREXEL.com/
-----Original Message-----
From: J. Michael Grindel [mailto:mgrindel@epdps.com]
Sent: 06 March 2002 21:24
To: RegAffairs
Subject: DDX and CTX
What is the relationship between the DDX
and the CTX exemptions for
clinical trials in the UK?
--------------------------------------------
J. Michael Grindel
mgrindel@epdps.com
EPD Pharma Solutions, LLC
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