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The Brazilian national agency (ANVISA) requests that a complete pre-analytical dossier and a rigorous comparison with the reference product be available.
As is the case for the development of any new diagnostic or therapeutic drug, this work would take many years and cost millions of euros, requiring the elaboration of a complete dossier, including optimisation of manufacturing and analytical methods, establishment of pharmacological and radiation safety and extensive clinical studies to demonstrate the real clinical value and profit.
NMR and LC-MS analytical methods are then applied not only to assess the purity of the compounds but also to generate the dossier of spectra needed to elucidate the structure of the novel compounds [ 60].
He kept a dossier on the case.
Analytical thinking?
Analytical creativity.
The dossier has been handed to investigators.
His dossier is among the most chilling.
Give them analytical tools.
It's very analytical.
They were analytical, even.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com