Background On January 2, 2020, Emery Pharma filed a Citizen Petition (Docket No. FDA-2020-P-0042) with the FDA regarding the drug Ranitidine, which appear to produce unacceptably high levels of a…
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If you are developing a gene-therapy-based product, which requires a Poloxamer quantitation assay and if you are a sponsor of investigational new drug applications (INDs) or applicant of new drug...
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Every drop of blood is a snapshot of our health. From the genetic makeup of our genes we are actively expressing, the concentration of metabolites in our body, to the...
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Why is it crucial to develop bioanalytical detection assays for poloxamers? Amphiphilic copolymers have been gaining significant attention due to their ability to simultaneously perform as both a hydrophilic and hydrophobic...
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At Emery Pharma, our team of expert bioanalytical chemists routinely provide R&D support and GLP services for our esteemed clients. Some of the services we provide include: method development, validation,...
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Nuclear Magnetic Resonance (NMR) spectroscopy is an incredibly powerful tool for characterizing molecular structures. When submitting to the FDA or other regulatory agencies, full structural characterization by NMR provides crucial...
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Oral delivery is the well-known administrative drug discovery path accepted by both patients and manufacturers. According to the recent report published in pharmaceutical technology, achieving optimal physicochemical properties of biomolecules,...
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I have worked in the drug discovery area for decades, and I often find that scientists, new or outside the field, to be very confused in the terminology used by medicinal…
The use of plants for their medicinal properties is probably as old as humankind itself, with written records going back for thousands of years. Plants and plant-derived products still play an…
Many natural products consist of a protein, peptide, or a small molecule which has been glycosylated. These glycosylations can happen for a variety of reasons, including cell-cell recognition of glycosylated...
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