Therapeutic or diagnostic applications

C5-1 antibodies to demonstrate the ability of alfalfa plants to produce large amounts of high-quality molecules for therapeutic or diagnostic applications. 

Some therapeutic or diagnostic applications of metal complexes, thus excluding the mechanical use of metals in biomedical applications, are listed in Table 1. 

Despite the evidence for the cytotoxicity of CNTs, there are an increasing number of published studies that support the potential development of CNT-based biomaterials for tissue regeneration (e.g., neuronal substrates [143] and orthopedic materials [154—156]), cancer treatment [157], and drug/vaccine delivery systems [158, 159]. Most of these applications will involve the implantation and/or administration of such materials into patients as for any therapeutic or diagnostic agent used, the toxic potential of the CNTs must be evaluated in relation to their potential benefits [160]. For this reason, detailed investigations of the interactions between CNTs/CNT-based implants and various cell types have been carried out [154, 155, 161]. A comprehensive description of such results, however, is beyond the scope of this chapter. Extensive reviews on the biocompatibility of implantable CNT composite materials [21, 143, 162] and of CNT drug-delivery systems [162] are available. 

As discussed in the initial chapters of this book, genetically modified animal cells are commonly used to obtain proteins for therapeutic, prophylactic, or diagnostic applications. The problem is that obtaining... 

Because each therapeutic or diagnostic situation is different, there can be no predetermined measure of the amount of data that must be submitted with each application. Therefore, an NDA should be submitted only when the sponsor is convinced and satisfied that the safety and efficacy of the drug product have been established to the degree required by the FDA to permit appropriate use by medical practitioners for the prevention or alleviation of human suffering. 

Monoclonal The preclinical testing strongly depends on the type of product, intended frequency antibodies of application, dose, intended clinical therapeutic or diagnostic effect and should be decided on a case by case basis. Complement-binding and cross-reactivity with human tissue should be tested. 

Iontophoresis is a method of transferring substances to and from the body for therapeutic or diagnostic purposes by applying an electric potential to enhance their movement across biological membranes. The most common applications of iontophoresis involve the delivery of therapeutic substances across the skin, though there are numerous examples of the use of iontophoresis to treat conditions of the eye, ear, nose, and mouth. Iontophoresis can also be used to remove substances (e.g., glucose) from the body. A technique known as microiontophoresis employs a small capillary probe to study cellular function by releasing precise quantities of active substances. 

As with any patent application, to obtain a patent on a gene, genetic component (e.g., EST or SNP), or diagnostic or therapeutic method, the applicant must demonstrate the utility, novelty, and nonobviousness of the discovery. The applicant must also supply a disclosure and written description of the subject of the proposed patent that is sufficient in detail to show that the inventor had possession of the claimed subject matter at the time of application and to enable one skilled in the field to make use of the claimed subject matter. Although the fundamental elements of patentability have been in place for decades for protection of such innovations as new mechani-... 

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