Bioequivalence and Bioavailability Survey Report

By Pharma Iq, PRNE
Wednesday, June 22, 2011

LONDON, June 23, 2011 -


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

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 href="">
2nd Annual Bioequivalence and
Studies, 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
Bioequivalence and Bioavailability Studies 2011
please visit
Bioequivalence and Bioavailability page, email or call +44(0)2073689421

Media contact: Joanna Checinska, +44(0)20-7368-9421, href="">
 - 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


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