Navigation Links
Bioequivalence and Bioavailability Survey Report
Date:6/23/2011

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, 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)



'/>"/>
SOURCE Pharma IQ
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. MonoSol Rx Completes Thin Film Ondansetron Pilot Bioequivalence Study
2. ADVENTRX Announces ANX-530 Safety Data From Registrational Bioequivalence Clinical Study
3. Insmed Announces First Human Bioequivalence Data for a Follow-on Biologic by a U.S. Company
4. MannKind Reports Successful Completion of Device Bioequivalence Trial
5. ADVENTRX Completes Patient Enrollment in ANX-514 Bioequivalence Study
6. ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
7. ADVENTRX Announces Results From ANX-514 Bioequivalence Study
8. Poniard Pharmaceuticals Oral Picoplatin Demonstrates Positive Bioavailability in Ongoing Phase 1 Trial
9. NKTR-118 Shows Substantial Oral Bioavailability and Extended Half-Life in Phase 1 Clinical Data Presented at American Pain Society Meeting
10. Fuisz Tobacco Announces Clinical Study Results for Fuisz Tobacco Sheet Strip; Super Enhanced Bioavailability of Nicotine From Its Tobacco Sheet Strip Supports Efficacy of Low Dose Tobacco Product
11. Intermezzo(R) 3.5 mg Achieves Greater Early Bioavailability Than Ambien(R) 10 mg Despite 65% Lower Dose
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/27/2016)... Switzerland , April 27, 2016 ... AG announced the launch of a Phase 2 clinical ... residual hearing in patients undergoing cochlear implantation (CI) surgery. ... recruiting patients in Germany and ... into the middle ear at the time of surgery. ...
(Date:4/26/2016)... 26, 2016 Hill-Rom Holdings, Inc. (NYSE: ... at the Deutsche Bank 41 st Annual Health Care ... You are invited to listen to the live ... access it directly at http://edge.media-server.com/m/p/mr4uxgas . A recorded replay ... of the live event and accessible at the links above ...
(Date:4/26/2016)... , April 27, 2016 Research ... "Global Molecular Diagnostics Market 2016-2020" report to their ... , ,The global molecular diagnostics market is projected to ... 2016-2020. Molecular diagnostics is a technique that ... the molecular level to detect changes in biochemical pathways. ...
Breaking Medicine Technology:
(Date:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... In ... a mother and divorcee, shares her enthusiasm for Botox and lip injections, which she ... world famous youth oriented Coachella Valley Music and Arts Festival. The article explains that ...
(Date:4/29/2016)... ... April 29, 2016 , ... ... , announces the addition Onnit brand Alpha BRAIN and New Mood Daily-Stress Formula ... brain and mood optimization products to the store is just one more way ...
(Date:4/29/2016)... ... April 29, 2016 , ... The American workforce ... stability, even security. Most importantly, employees are the single most important asset in ... workers so unhappy? , Just under half of American workers are emotionally checked ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... Conditions were ... at Cove Island Park on Sunday, with sunny skies, a light breeze and temperatures ... nearly $33,000. , The 5k Run and Walk and 1-mile walk were ...
(Date:4/29/2016)... ... ... Spine Team Texas, a comprehensive spine physician group specializing in the treatment of ... invited to be a featured speaker at the Texas Society of the American College ... , Dr. R. Scott McPherson, a physical medicine and rehabilitation specialist, will speak ...
Breaking Medicine News(10 mins):