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:10/10/2017)... -- NDS received FDA 510(k) clearance in May 2017 for its highly ... designed for endoscopy environments. An innovative secondary monitor solution, ZeroWire ... support the improvement of patient outcomes, procedural efficiency, and the lowering ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology:
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... , ... October 13, 2017 , ... Global Healthcare Management’s ... Alexandria Park in Milford, NJ. This free event, sponsored by Global Healthcare Management’s ... The fun run is geared towards children of all ages; it is a ...
(Date:10/13/2017)... ... October 13, 2017 , ... “The Journey: From the ... danger possible to save lost souls in the Philippines. “The Journey: From the Mountains ... a dedicated teacher of the Bible. She has taught all ages and currently teaches ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and ... plans to open a flagship location in Covington, LA at 401 N. U.S. Highway ... store next to Office Depot in the Holiday Square shopping center. Its location allows ...
(Date:10/12/2017)... ... 2017 , ... Asante, a nationally recognized health system in ... existing home health joint venture through an agreement, effective October 1, 2017, to ... home health company with Asante, delivering clinically integrated care, for the past eight ...
Breaking Medicine News(10 mins):