Products Approved for Human Use

Alternatively, some subunit viral vaccines can be generated by rDNA techniques and expressed in a continuous ceU line or insect ceUs. Recent advances in bioreactor design and operation have improved the successful production of IPV in large-scale bioreactors. However, roUer bottles or flasks are stiU used for most current vaccine production. Development of insect ceU culture will allow for very large-scale Hquid suspension culture (143). Several vaccine candidates such as gpl60 for HIV and gD protein for herpes have been demonstrated in the insect ceU culture system. However, no vaccine has been approved for human use. 

As of late 2006, no pharm-produced drug had as yetbeen approved for human use by the U.S. Food and Drug Administration. A number of products were "in the pipeline, however, at various stages of the... 

This antibiotic class has the highest number of antibiotics on the market. All P lactam antibiotics have a basic fl-lactam ring structure and other classes are categorized based on the structure of the ring adjacent to the beta-lactam ring (Fig. 3). The majority of the fl-lactams derived from natural products and approved for human use are listed in Table 2. 

BOX 11.1. HOW A VACCINE PRODUCT IS APPROVED FOR HUMAN USE BY THE FOOD AND DRUG ADMINISTRATION IN THE UNITED STATES... 

The net result of these three factors is that many drugs or vaccines simply remain in IND status for indefinite periods. The IND (or not yet approved for human use) status may mean that the product in question is genuinely experimental. Or it may simply mean that it has not been licensed because an NDA or BLA has never heen submitted. However, in some cases a not-yet-approved drug or vaccine may be the hest available treatment—better than no treatment or better than an approved treatment of limited effectiveness—for a very specific medical use. This is true for certain drugs or vaccines for countering CBW threats, for which DoD holds the INDs. (It is also true for certain public health vaccines, in which the IND is held by the Centers for Disease Control and Prevention.)... 

An effective and compliant stability program will ensure that drug products developed for human use are safe, efficacious, and will meet a certain standard of quality (i.e., remain within its approved shelf life specification when exposed to various storage conditions). As the product may experience extreme temperatures and/or humidity as it moves through the supply chain from manufacturer to pharmacy to consumer, it is imperative to determine what effect these conditions will have on product quality. A number of systems are implemented to guarantee that the stability program is carried out with these principles in mind. The elements of an effective stability program include ... 

TESTING (Physiological). Determination of (lie toxicity of a substance or product by administering it to laboratory animals in controlled dosages, by mouth, skin application, or injection. Materials commonly subjected lo such evaluation are plianuaceuheals, pesticides, and foods. Extensive testing programs are required before such products are approved for human use. 

The mucosal vaccines approved for human use include typhoid, cholera, adenovirus, Sabin oral polio, and rotavirus vaccines. New mucosal vaccine strategies are focused on development of non-replicating subunit vaccines, DNA, plant, and other types of recombinant vaccines as well as the use of mucosal adjuvants preferably inbuilt into the vaccine. The conjugation of lipids to peptide antigens is one approach which enables the production of highly... 

The FDA requires the manufacturer of a botanical product designed for human use to submit a new dietary ingredient (NDI) notification for any new ingredient that was not marketed in the United States before October 15, 1994 (DSHEA). Notifications should be submitted to the FDA 75 days prior to the marketing date and require information establishing a reasonable expectation of safety for products containing the NDI. The FDA does not approve or disapprove an NDI it may post objections. Examples of substances disallowed for use by the FDA include androstenedione, Ephedra, steroidal precursor substances, and aristolochic acid. 

Tetrachloroethylene (TCE) is the only halogenated hydrocarbon anthelmintic holdover from the nineteenth century because of its specific efficacy against hookworm. Of course, it has all the hazards attributed to alkyl halide use in humans. Safer drugs should now be utilized. It is interesting that although TCE is still approved for human use in the United States, it is only available as a veterinary product (Nema). 

Influenza A viruses cause severe infections in the respiratory system and are responsible for seasonal epidemics and sporadic pandemics. The primary method for prevention is through vaccination but vaccine production by current methods cannot be carried out in time to stop the progress of a new strain of the influenza virus. Therefore, effective antiviral agents are used for prophylactic and therapeutic treatments. Among several viral molecular targets for anti-influenza drugs, the surface glycoprotein neuraminidase appears particularly attractive. Selective inhibitors of this enzyme have been developed and two of which, oseltamivir phosphate 18 (Tamiflu ) " and zanamivir 19 (Relenza ), have been approved for human use (Scheme 6). 

Reporter genes can also encode for extracellular receptors such as dopamine D2 (200) and SST type-2 receptors (201), or membrane transporters such as the sodium/iodide symporter (202). These human genes have been suggested as candidate reporter genes because they exhibit limited expression in the body. At the same time, radiolabeled tracers with high affinity for these extracellular gene-products have been extensively studied and are approved for human use [e.g., [ F]fluoroethylspiperone for D2 receptors (203), " in-pentetreotide for SST receptors (121), and 123/124/I3ij... 

Sorbitan oleate and the monolaurate are pale yeUow Hquids. Palmitates and stearates are light tan soHds. Sorbitan esters are not soluble in water but dissolve in a wide range of mineral and vegetable oils. They are lipophilic emulsifiers, solubiHzers, softeners, and fiber lubricants that find appHcation in synthetic fiber manufacture, textile processing, and cosmetic products. Sorbitan esters have been approved for human ingestion and are widely used as emulsifiers and solubiHzers in foods, beverages, and pharmaceuticals. 

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