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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
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August, and November

News and Press Releases

MedPharm accelerates strategy to broaden service offering into commercial manufacturing

MedPharm Ltd, a leading contract provider of topical and transdermal product design and development services, has announced two new appointments to its Board to support plans to grow its commercial manufacturing services.
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White Papers

Orthogonal Approaches for the Analysis of Protein Sequence and Post Translational Modifications of a Monoclonal Antibody

RSSL

Monoclonal antibodies are an important class of biopharmaceuticals. They are expressed from living cells and therefore, are subject to complex biochemical pathways. Not all of these pathways are fully understood and many are known to be sensitive to subtle environmental changes during production. These changes may affect the final biopharmaceutical sequence, structure and post-translational modifications. This is in addition to any changes that may occur during subsequent purification. This means that the final product from one batch may be subtly different from another batch. Furthermore, each batch is a heterogeneous mix of similar molecules. Analysis of the degree of batch-tobatch variation, and batch heterogeneity, is therefore, very important to establish in order to be confident that the drug is safe and effective for medicinal use.
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Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

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