21st Century Cures Act
The FDA is continually working to improve patient outcomes by including patients as well as their comfort and safety in
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biologics
Pharmaceutical Drug Development (Small Molecules / Large Molecules)
In the world of pharmacology and drug development, there are two ways to classify the molecules used, as small and
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Immunogenicity of Biologics
The US Food and Drug Administration defines biologics as “a wide range of products such as vaccines, blood and blood
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Regulation of Biological Products and Biopharmaceutical Products
Biological products comprise a wide array of products, all of which are regulated in the US by FDA’s CBER (Center
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Ligand Binding Assays (LBAs)
Ligand binding assays is an analytical procedure commonly used for large molecules, that relies on ligand molecules binding to macromolecule
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Biosimilars
Biosimilars are a class of pharmaceutical drug products that are similar to a currently licensed FDA biological product. Biosimilars can
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