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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Biologics
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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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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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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Residual DNA Testing | Host Cell DNA Analysis
Residual DNA testing, or host cell DNA analysis, is the examination of products for traces of DNA that have been
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Biomarkers | Disease Detection
Biomarkers, also called biological markers, are measurable indicators of a biological condition. The exact definition is “a characteristic that is
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FDA recommends Zika virus testing on all donated blood in USA
On August 26, 2016, The US Food and Drug Administration (USFDA) recommended universal Zika virus testing of all donated blood.
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Potency Testing of Biopharmaceuticals
Potency testing is a term used to describe the process of measuring biological activity in a product. Many methods exist
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Endocrinology Hormone Testing
Endocrinology hormone testing is important to determine the functioning of the endocrine system. Endocrinology is the study of the endocrine
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