Cyprotex PLC Updated Regulatory Guidance Booklet
August 02 2012 - 2:01AM
RNS Non-Regulatory
TIDMCRX
Cyprotex PLC
02 August 2012
2(nd) August 2012
Cyprotex PLC
Cyprotex launch their updated Drug-Drug Interaction Regulatory
Guidance booklet to reflect the new FDA and EMA guidelines
Cyprotex PLC (AIM:CRX), the ADME Tox specialists, have today
launched an update of their popular Drug-Drug Interaction
Regulatory Guidance booklet.
Important new regulatory guidelines for drug-drug interaction
(DDI) studies have been released this year. Initially, draft FDA
guidance for drug interactions studies were released for comment in
February. In June, the European Medicines Agency (EMA) adopted a
new guideline on the investigation of drug interactions and this is
due to come into effect as of January 2013.
By popular request from our customers, Cyprotex have constructed
an easy-to-follow pocket-sized handbook entitled 'DDI Regulatory
Guidance - An easy to follow guide' which summarises key
information from the latest drug interaction guidance documents. It
offers a side-by-side comparison of the recommendations from both
the FDA and EMA regulatory authorities. The handbook assists in the
design and planning of in vitro DDI studies and provides concise
information on how the data are used to guide clinical DDI
studies.
Commenting on the launch of the handbook, Dr. Anthony Baxter,
Chief Executive Officer of Cyprotex, said: "Our DDI handbook
provides a valuable resource for scientists who can now access the
key information from the regulatory authorities in an easy-to-read
format. The handbook also acts as an educational tool for new
scientists in the field who are unfamiliar with these guidelines.
We have had an overwhelming response to the revised handbook, with
over 500 potential customers already pre-ordering the updated
version, which will be distributed later this week."
To request a copy of the DDI handbook, visit:
http://www.cyprotex.com/ddiguide/
For further information:
Cyprotex PLC Tel: +44 (0) 1625 505
100
Dr Anthony Baxter, Chief Executive Officer ir@cyprotex.com
John Dootson, Chief Financial Officer www.cyprotex.com
Mark Warburton, Chief Operating Officer
and Legal Counsel
Singer Capital Markets Limited (broker to Tel: +44 (0) 20 3205
Cyprotex) 7500
Shaun Dobson shaun.dobson@singercm.com
Claes Spang claes.spang@singercm.com
www.singercm.com
FTI Consulting Tel: +44 (0) 20 7831
3113
Ben Brewerton cyprotex@fticonsulting.com
Simon Conway www.fticonsulting.com
Mo Noonan
Notes to Editors
About Cyprotex PLC
Cyprotex is based in Macclesfield, near Manchester in the UK,
and Watertown, Boston in the US and is listed on the AIM market of
the London Stock Exchange (CRX). The company was established in
1999 and works with more than 700 partners ranging from small
biotechs to large pharma companies. Cyprotex acquired Apredica and
the assets of Cellumen Inc. in August 2010 and the combined
business provides support for a wide range of experimental and
computational ADME-Tox and PK services, extending from early drug
discovery through to IND submission. The company's core
capabilities include high quality in vitro ADME screening services,
mechanistic toxicology and high content toxicology screening
services and predictive modelling using PBPK and QSAR techniques,
including Cloe(R) PK for in vivo PK prediction. For more
information, see www.cyprotex.com.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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