Frequency Of Administration

To establish the maximal efficacy for the treatment of certain diseases or for the creation of robust vaccines, injections, or administrations of the nonviral gene therapeutic, etc., via dif ferent routes may be required. For particular treatments, one should not assume that one delivery route is superior to others without performing the appropriate animal experiments. In addition, people with the appropriate expertise should perform the injections and administrations. In our experience, only a minority of people who claim expertise in performing tail vein injections can actually perform optimal injections.

The optimal dose should be determined for each therapeutic gene or other nucleic acid that is administered. The investigator should not assume that the highest tolerable dose is optimal for producing maximal efficacy. The optimal administration schedule should also be determined for each therapeutic gene or other nucleic acid. To progress faster, some investigators have simply used the same administration schedule that they used for chemotherapeutics, for example. The investigator should perform in vivo experiments to determine when gene expression and/or efficacy drops significantly. Most likely, readministration of the nonviral gene therapeutic is not necessary until this drop occurs. Loss of the therapeutic gene product will vary with the half-life of the protein produced. Therefore, if a therapeutic protein has a longer half-life, then the gene therapy could be administered less frequently.

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