A Third of Bioequivalence and Bioavailability Experts Find the Ability to Secure Biowaivers a Main Concern, Says Recent Pharma IQ Survey



Pharma IQ News
06/30/2011

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 per cent 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 per cent 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, 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, 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)