Many biologic are proteins that produce highly specific responses in cell cultures or that produce antibody-antigen reactions in vitro. Radio-immune assays are available for specific antibody-antigen reactions, and so concentration of the biological candidates can be measured directly against its ability to form antibody-antigen complexes. Similarly, when proteins produce specific responses in cell cultures, the degree of response can be measured as a function of the concentration of the biologic.
Thus, the projection of human doses for most biologic is similar to the projection of human doses for anti-infective agents. Once the necessary concentration of the agent is determined, the human pharmaco-kinetics can be used to determine the dose that will produce that concentration.
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