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European Pharmaceutical Contractor

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Winter 2017

   
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Clinical Trials
Enrolment Challenges

Global Goals

With elements ranging from clinical constraints to cultural and global regulations, coordinating a clinical trial can be challenging. Debbie Elliott, Colleen Grawe, Jaqueline Moore and Gina Steidle at Medpace examine the decisions involved.
 
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Designing First-in-Human Studies

Plotting the Route

Reaching that first-in-human trial is a significant step in all clinical research. Dr Torkel Gren at Recipharm Pharmaceutical Development and Anders Millerhovf at CTC Clinical Trial Consultants explore options for simplifying the process.
 
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Trial Design Precautions

Suggestions for Success


Nuala Ronan and Deborah Arthur at Databean take a look at how regulations and increased costs can be reduced for small businesses and start-ups developing medical devices.

 
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Published quarterly in
February, May,
August and November

News and Press Releases

POP TEST ADDRESSES THE PROBLEM OF UNRELIABLE DATA FROM CONTINUOUS GLUCOSE MONITORS

A major insight relating to the unreliability of data from continuous glucose monitors was published in the Nature journal, “Scientific Reports”, by Neil Theise, MD., the Lead Scientist of Pop Test, LLC and colleagues. The discovery of the “Interstitium”, a newfound human organ, by Dr. Theise and his collaborators, can be viewed by using the link https://www.nature.com/articles/s41598-018-23062-6 Continual glucose monitoring via an indwelling cutaneous needle measuring glucose in interstitial fluid (now identified to be in the “interstitium”) has been a game changer in the treatment of type 1 diabetes mellitus because of its accuracy. However, the needles used to collect this glucose containing fluid often fail in as little as a week. Despite the reliance on fluid from this space, the microanatomy of the interstitium has never been defined. The sensors currently in use were developed with the presumption of interstitial fluid being located somewhere in the sub-epidermal layers of the skin, but the actual anatomy relating to needle placement was always unclear.
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White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
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Industry Events

ChinaBio Partnering Forum 2018

25-26 April 2018, Kempinski Hotel Suzhou, Jiangsu, China

Access a world of opportunities through life science partnering in China. ChinaBio® Partnering Forum is the premier life science partnering event in China. The conference will be held April 25–26 in Suzhou, attracting biotech and pharma leaders from around the world along with hundreds of China-based developers of novel technologies for two days of productive partnering.
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