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Last updated on April 16, 2014 at 21:24 EDT

Bioequivalence and Bioavailability Survey Report

June 23, 2011

LONDON, June 23, 2011 /PRNewswire/ –

Pharma IQ has just published the results of an Industry-wide
Bioequivalence and Bioavailability Survey, conducted recently among 2,000
bioequivalence and bioavailability experts.

The results showed that 33.3% of respondents found the ability to secure
biowaivers as their main concern; another third said it was validating
IVIVC. Two-thirds of the respondents said that the most important factor
when choosing a service provider was a strong working relationship. Only a
third of companies were more concerned by the upfront cost, while a CRO’s
reputation alone would not be enough to sway any of the participants.

With regard to the satisfaction with their current service providers,
66.7% of companies would not rush to change service provider while the
remaining third claimed to be not entirely pleased with their partner’s
offering.

The survey was created as a part of the pre-conference research for 2nd
Annual Bioequivalence and Bioavailability Studies
[http://www.bioequivalenceevent.com/Event.aspx?id=532214&utm_campaign=PR&utm_medium=online&utm_source=Press_ReleasesBR&MAC=19113.001 ]
, taking place 19-20
September, 2011 in Brussels. The results helped to shape the agenda and the
final speaker line-up which features AGES providing the delegates with an
overview of current guidelines and National Institute for Pharmacy
Directorate from Hungary sharing a regulatory perspective on the EMA
bioequivalence guideline one year on. BfArM will outline the EU guideline on
the validation of bioanalytical methods.

Other important topics expressed by survey respondents and will be
discussed at the event include:

        - Translating (non-) bioequivalence results to clinical (IR)
          relevance through integrated modelling and simulation of PK/PD-
          efficacy/safety - Case Study from Merck
        - Challenges in the design of comparative bioavailability studies:
          experiences from industry - Case Study from Synthon BV
        - Industry experience with the EMA bioequivalence guideline - Case
          Study from EGA Bioequivalence Working Group

        - Tips from the regulators for successfully securing a
          biowaiver (State Institute for Drug Control, Czech Republic)

To access the full survey report or to find out more about
Bioequivalence and Bioavailability Studies 2011 please visit Bioequivalence
and Bioavailability page
[http://www.bioequivalenceevent.com/Event.aspx?id=532214&utm_campaign=PR&utm_medium=online&utm_source=Press_ReleasesBR&MAC=19113.001 ]
, email enquire@iqpc.co.uk
or call +44(0)2073689421

Media contact: Joanna Checinska, +44(0)20-7368-9421,
joanna.checinska@iqpc.co.uk – Please contact for more information or images.

Press are invited to attend this important industry forum, if you would
like to a complimentary press pass please email Joanna Checinska
(joanna.checinska@iqpc.co.uk)

SOURCE Pharma IQ


Source: newswire