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However, significant efforts need to be invested into characterizing and validating covalent molecules as a prerequisite for conclusive use in biomedical research and target validation studies. Carefully designed biochemicalassays used in determining IC50 values can be well-suited as surrogates for k.inact/K.i measurements. (
For example, in describing how potency should be demonstrated for CGT products, the 2011 guidance simply stated that potency for gene therapy products is derived from “at least two biological activities for its potency: the ability to transfer a genetic sequence to a cell; and the biological effect of the expressed genetic sequence.”
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Biochemical Assays 
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