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| home > white papers > Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences - Myoderm |
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 WHITE PAPERS |
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Myoderm
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Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences
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Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supply availability, lead times, and documentation are just a few. In the past, there were fewer clinical trials that required commercial drug sourcing, so demand was not as high. Today, the demand for commercial drugs in clinical trials has greatly increased and, as a result, inventory is tighter, orders are monitored more closely by manufacturers, and lead times have increased. This report highlights the key differences in sourcing from the US and EU.
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News and Press Releases |
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Leading pharma packaging companies commit to supply for Covid-19 fight
The CEOs of Gerresheimer, Stevanato Group, and SCHOTT are committed to ensuring ample supply of pharmaceutical containers for any Covid-19 vaccine and treatment that is developed, and that no patient shall be left behind, no matter what region of the world they live in. Also, the companies will make every effort to support the pharma industry’s’ priorities for overall medication supply in addition to Covid-19 drugs. Each of the three companies manufactures billions of type-1 borosilicate glass vials, the most proven and most widely available material used to store and deliver vaccines around the world. They are making the statement to provide confidence in the global pharmaceutical supply chain in times of uncertainty.
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White Papers |
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Life Cycle of an Analytical Method - a Case Study on the Monocyte Activation Test
Wickham Laboratories Limited
Pyrogens, a heterogeneous group of fever inducing contaminants, are comprised of microbial and non-microbial compounds; e.g. endotoxin (lipopolysaccharide, LPS) produced by Gram-negative bacteria, lipoteichoic acid (LTA) from Gram-positive bacteria, bacterial DNA (CpG-motive), endogenous pyrogens, virus and fungi particles or even fragments of packaging materials, plastic and dust. Contaminat ion wi th pyrogens in pharmaceutical products, biotherapeutics and on medical devices can lead to life threatening fever reactions. To ensure consumer safety, pyrogen testing is mandatory for parenteral products and medical devices.
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Industry Events |
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INTERPHEX 2020
15-17 July 2020, Javits Center NYC
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