spacer
home > epc > winter 2018 > smooth sailing
PUBLICATIONS
European Pharmaceutical Contractor

Smooth Sailing

Clinical trials are performed to accumulate the required information about safety and efficacy of new medicinal products including small and large molecules or medical devices. Before those products hit the healthcare market – if at all – the authorisation procedure passes through numerous steps and stages. In this process, the analysis of clinical samples represents only a minor, but important, portion. Next to safety laboratory testing (which is mandatory in monitoring a new drug), results of lab analyses also provide important evidence on the mode of action of the new medicinal product in vivo.

Pharmacokinetic (PK) tests reveal the buildup of the plasma level of the drug and its successive metabolism and excretion over time. Pharmacodynamic (PD) analyses shed a light on the mode of action of the substance in the human body. More biomarker molecules are being described as an indicator for various physiological conditions. Hence, with each measurement, the researchers gain essential insight into biological processes within the human body.

Subcontracting a Central Lab


For a number of years already, clinical studies have had a tendency to become more complex, consequently leading to challenging analytical demands. Therefore, in multinational trials, many sponsors decide to subcontract one central lab provider instead of many local labs, which results in a broader service portfolio as well as a more efficient sample management and readily comparable lab data.

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
Dr Sarah Waelde is Manager Business Development at SYNLAB pharma institute – a leading provider of central lab and advanced diagnostic services for the pharma industry, performing general strategic and tactical account-planning next to managing customer relationships. Her expertise in the pharma sector derives from several years of extensive sales. Sarah holds a degree in biology and spent three years as a Postdoctoral Researcher at the YALE School of Medicine, US, investigating the activation of mitotic entry in fission yeast.

Dr Holger Schoeneborn
has more than 15 years of experience in the pharma industry. After 11 years in project management and involvement in more than 100 clinical trials, he is now heading the sample management department and scientific support at SYNLAB pharma institute in Munich. Holger holds a PhD degree in biology from the Technical University Munich, Germany.

spacer
Dr Sarah Waelde
spacer
spacer
spacer
Dr Holger Schoeneborn
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

PPMA Group Industry Awards 2018 Call for Entries – Deadline 31st July

The PPMA Group Industry Awards, which recognise manufacturing excellence, technical innovation, entrepreneurship as well as outstanding achievement and contribution to the industry, will this year take place at a new venue – the Hilton Birmingham Metropole Hotel at the NEC - on the 25th September 2018.
More info >>

White Papers
 
Industry Events

SAPHEX 2018

1-2 November 2018, Gallagher Convention Centre, Midrand, South Africa

The SAPHEX exhibition and conference is now established as the “go-to” networking and business event for anyone working in the South African pharmaceutical manufacturing industry.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement