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Intended for screening blood, organ, and tissue donors, the new test will improve blood safety and availability Roche announced FDA approval of cobas® Malaria test for use on cobas® 6800/8800 Systems. The test aids in reducing risks of patient infection from...
Join us as Brent Hilker, Manager, Preformulation CoreRx explains the techniques and challenges associated with today's drug development
Ensuring product sterility is vital for patient safety, regulatory compliance, and quality assurance across pharmaceutical, medical device, and biotech sector
FOR IMMEDIATE RELEASEJanuary 31, 2024 The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH) As CDRH moves into 2024 and beyond, the Center intends to initiate the reclassification process for...
In recent years, the FDA has identified several concerns with laboratory developed tests ( LFTs)
If your company is developing or manufacturing a medical device, it may be required to have testing according to AAMI Consensus Standards. The Association for the Advancement of Medical Instrumentation® (AAMI) is a nonprofit organization that is focused on the...
Drug formulation is and continues to be challenging. Every product is different. Every drug behaves differently based on its physicochemical properties. Understanding those properties through preformulation and in vitro permeability testing is important in designing an appropriate dosage form.
The Therapeutic Goods Administration, or TGA is a division of the Australian Government Department of Health. The TGA is responsible for regulating therapeutic goods, like prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood and blood products.
ADME (absorption, distribution, metabolism, and excretion) studies are designed to investigate how a chemical is processed by an organism.
We received this request yesterday at Contract Laboratories! Diet supplements are always a popular industry, but egg yolks are a unique testing medium! let's spotlight this test request and dig a little deeper into IgY assays.
The CAM assay, or Chorioallantoic Membrane assay, is a technique in biological research that involves the using a developing chicken embryo for experimental purposes.
Just like for human supplements, the role that laboratories play in testing dog hip and joint supplements is indispensable
Not Exactly How TV Shows Perform Unknown Substances Testing Often exaggerated and glamorized in television shows, unknown substance testing isn't as glamorous or speedy in real-life laboratories. We’ve all seen it in those classic scenes—the main characters stumble...
Explore the roles and importance of various antibodies such as IgG, IgM, and IgA in the human immune system, and how they protect the body from infections and diseases Antibodies play a crucial role in the body's immune response, acting as a key defense mechanism...
The classification and significance of molecules in pharmacology and their distinct properties. 90% of current drugs are small molecules, but large molecules are quickly rising in popularity and importance. In the world of pharmacology and drug development, the...
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Discover the blend of science and sustainability that ensures products are...
From safety culture to a culture of safety, protecting workers from harm is...
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