The delivery of parenteral therapeutics through an intravenous (IV) route often involves contact with different materials associated with IV-administration devices. "In-use" stability studies are designed to ensure no loss of product quality during storage and administration. However, excipients, ...
Imagine you are working or traveling away
from your home when an emergency repair
crops up. You can’t handle it personally, but
you know someone who can – and one call to
that person takes care of it.
Twenty years ago, the risk to drug substance/product quality due to
temperature excursions during shipping was not generally appreciated.
A series of studies led to several papers in USP PF which documented
some of the risks1-4. In response, increasing regulatory requirements
related to supply ...
Global air freight industry contributes with 0.5% of global world trade in volume but raises at the same time up to 35% of its value or $6.4 trillion according to Air Transport Action Group (ATAG). Managing the transportation of temperature controlled products (refrigerated and frozen) will total $...
Recent advances in translational and personalized medicine initiatives has led to a marked increase in biomarker driven research objectives within clinical trials, thus requiring innovative mechanisms and best practices to manage biomarker specimens collected in global clinical driven trials. To ...