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cGMP
- cyclic GMP.
Example Sentences
In November 2020, one outside consultant to Emergent laid out the stakes in stark terms, noting that the firm was deviating from Current Good Manufacturing Practices, or CGMP.
Stanley and co-workers observed that vasodilation mediated by cis-WOOH needs much less cGMP than does blood-vessel relaxation mediated by kynurenine, but still requires activation of PKG1α.
However, the link between cis-WOOH and vasodilation does not depend on cGMP, but rather on PKG1α oxidation, so the authors’ proposal cannot explain the earlier findings.
Concurrent with clinical studies, companies usually complete additional animal studies and must also develop additional information about the chemistry and physical characteristics of the pharmaceutical product as well as finalize a process for manufacturing the product in commercial quantities in accordance with cGMP requirements.
After the NDA submission is accepted for filing, the FDA reviews the NDA application to determine, among other things, whether the proposed product is safe and effective for its intended use, and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity.
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