Notable excerpt: "The present invention provides methods and compositions for evaluating one or more properties of a candidate agent (e.g., an amino acid copolymer, e.g., Copolymer-1; e.g., glatiramer acetate). In one aspect, the invention provides a variety of embodiments for evaluating an amino acid copolymer preparation for physiological, pharmacodynamic, pharmacokinetic, or pharmaceutical properties including but not limited to potency, specificity, stability, biological activity, e.g., for suitability as a pharmaceutical preparation, e.g., for the treatment of autoimmune and/or inflammatory disease, disorders or dysfunctions."
Although, looking at this, I see it's all in vitro, and I don't see the embodiments relating to PK and PD, that is, if they are there, I am not recognizing them as such. Would the FDA go for this?
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