spacer
home > epc > summer 2018 > innovative indication
PUBLICATIONS
European Pharmaceutical Contractor

Innovative Indication

In the early days, biomarkers were used primarily as physiological indicators for blood pressure or heart rate, as examples. A biomarker is an objective indication of a particular medical state observed from outside the patient, which can be measured accurately and reproducibly.

More recently, biomarkers, such as elevated prostate specific antigen, can be used as a molecular biomarker for prostate cancer or enzyme assays used as liver function tests. A biomarker is anything that can be used as an indicator of a disease state or some other physiological state of an organism.

According to Strimbu and Jorge, the use of biomarkers in basic and clinical research, as well as in clinical practice, has become so commonplace that their presence as primary endpoints in clinical trials is now accepted almost without question (1).

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
Professor Christene Leiper attended Sydney University, RMIT Melbourne, and Bond University, Australia, and achieved a Professorship of Medicine and Life Sciences at Bond University in 2006. She also undertook research at Edinburgh University, Scotland, as part of her PhD. Christene has been a principal investigator for clinical trials, which enables her to operate across many disciplinary boundaries within clinical research in a coherent and productive manner. In 2007, she was appointed Director of Research at a Scottish CRO, which, in turn, led her to start her own CRO, Onorach, in 2009.
spacer
Professor Christene Leiper
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

CBIs Global Risk Based Monitoring Event

CBI’s Global Risk Based Monitoring Event is approaching, taking place in London on 13 – 14 September 2018, designed for benchmarking with international peers to gauge RBM performance, efficiencies, implementation and technologies.
More info >>

White Papers

The Impact of Components on Drug Quality and Risk Mitigation

West Pharmaceutical Services, Inc.

Expectations for quality by regulatory agencies are increasing at a very fast pace, especially for prefilled drug delivery formats, thanks to increased focus on reducing risk to patient safety. The trend has resulted in delays for new drug applications, more recalls of marketed products and even drug shortages if the container system and drug contents are suspect for quality issues. The pharmaceutical market is now requiring manufacturers of containers and components to meet new expectations with a quality culture and very high product reliability. The need to bridge the gap and provide superior quality products has been a driver for manufacturing technology investments, more robust control strategies and the introduction of next generation elastomer components.
More info >>

 
Industry Events

Partnerships in Clinical Trials Europe 2018

27-29 November 2018, CCIB, Barcelona

Partnerships in Clinical Trials Europe is back – and bigger than ever. Europe’s most complete clinical meeting is bringing together 1000+ of the industry’s leading experts this November for it’s 17th annual gathering, and you’re invited!
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement