samedan logo
 
 
 
spacer
home > ebr > autumn 2002 > editor's letter
PUBLICATIONS
European Biopharmaceutical Review

Editor's Letter

Times are not just tough, they have changed - a stark message but one interpretation of the environment that the European biotechnology sector faces today. As the chillier weather sets in and the hectic autumnal partnering season approaches, it will be interesting to hear whether some of the predictions and sentiments voiced within this issue receive further air time on the partnering conference stage. By volume of companies and people employed, as well as private equity investment, the European sector continues to grow strongly as reflected in DeLoitte & Touche's recently launched annual Mediscience Report, reviewed in this issue. However, the majority of this growth is within established companies, trying to progress technologies towards products and build value and sustainable critical mass 'until' the IPO window opens again. Therein seems to lie perhaps the more fundamental environmental change as institutional investors continue to show less than a glimmer of interest in biotechnology stocks.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Dr Helen Abbott, Senior Consultant at Technomark Consulting Services
spacer
Dr Helen Abbott
spacer
spacer
spacer
Deirdre Ruane
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Language Weaver now available for ServiceNow customers

RWS, the world’s leading provider of technology-enabled language, content management, and intellectual property services, has released a new Language Weaver Connector for ServiceNow
More info >>

White Papers

Backward Thinking: The Reverse Engineering of A Pressurized Metered Dose Inhaler

Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market. Significant information about the reference marketed product can be obtained from a thorough review of published literature, specifically the Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL). Additionally, baselining the reference marketed product for pharmaceutical performance offers a working target specification for in-vitro correlation. It will ensure the smoothest possible path to commercialization and maximize return on investment. In addition, baselining of the reference marketed product is done to understand batch-to-batch variability and product performance over the stated shelf life to establish targets for critical quality attributes (CQAs), which can be applied to the generic equivalent pMDI.
More info >>

 

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement