Human uses

Wood is one of the oldest constmction materials in human use and continues to be an extremely valuable material to this day. Wood is lightweight, strong, stable, easily worked and fastened, a good insulator, warm to the touch, and pleasing in appearance, among many other attributes. 

New dmg apphcation (NDA) is the process through which the U.S. Food and Dmg Administration (FDA) authorizes the marketing of a new dmg. In the NDA, the data are intended to demonstrate the safety and efficacy of the dmg in its intended apphcation. After approval, the dmg becomes available to the pubhc. Subsequendy, dosage amounts and forms may be modified according to experience, new indications may be added, and contraindications may be noted. All of the changes requite regulatory approval. A dmg in human use is subject to constant surveillance. 

The demonstration that injected or force-fed neonatal rodents given extremely high doses of MSG showed evidence of brain lesions, has led to much additional research to determine any possible link between neurotoxicity and human use of MSG (33). However, no evidence from animal tests indicates that MSG in the diet causes brain damage in humans (34). 

Many other compounds are presendy in use a 1993 database search showed 27 active ingredients in 212 products registered by the U.S. EPA for human use as repellents or feeding depressants, including octyl bicycloheptene dicarboxamide (A/-2-ethylhexylbicyclo[2.2.1]-5-hepten-2,3-dicarboxamide), dipropyl isocinchomeronate (2,5-pyridine dicarboxyhc acid, dipropyl ester), dimethyl phthalate, oil of citroneUa, cedarwood oil, pyrethrins, and pine tar oil (2). Repellent—toxicant or biting depressant systems are available which are reasonably comfortable for the user and can protect completely against a number of pests for an extended period of time (2). 

Sutures are regulated by the EDA as medical devices iatended for human use. The Eederal Eood, Dmg, and Cosmetic Act of 1938 has been amended many times, ia particular by the Medical Device Amendments of 1976. Devices have been under the jurisdiction of the EDA siace 1938. Section 513 of the Act requires the EDA to classify medical devices (sutures) ia one of three categories as follows. 

Polyurethanes. These polymers can be considered safe for human use. However, exposure to dust, generated in finishing operations, should be avoided. Ventilation, dust masks, and eye protection are recommended in foam fabrication operations. Polyurethane or polyisocyanurate dust may present an explosion risk under certain conditions. Airborne concentrations of 25—30 g/m are required before an explosion occurs. Inhalation of thermal decomposition products of polyurethanes should be avoided because carbon monoxide and hydrogen cyanide are among the many products present. 

Adjuvants are substances which can modify the immune response of an antigen (139,140). With better understanding of the functions of different arms of the immune system, it is possible to explore the effects of an adjuvant, such that the protective efficacy of a vaccine can be improved. At present, aluminum salt is the only adjuvant approved for use in human vaccines. New adjuvants such as QS-21, 3D-MPL, MF-59, and other liposome preparations are being evaluated. Several of these adjuvants have been in clinical trial, but none have been approved for human use. IL-12 has been proposed as an adjuvant which can specifically promote T-helper 1 ceU response, and can be a very promising adjuvant for future vaccine development. 

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. 

The biotin market is divided between agricultural and human use, with —90% of biotin used in the animal health care market and —10% for the human nutritional market. The major producers of biotin are Hoffmann-La Roche, Lon2a, E. Merck-Darmstadt, Rhc ne-Poulenc, Sumitomo Pharmaceutical, E. Sung, and Tanabe Seiyaku (100). Worldwide production of biotin in 1994 was approximately 60 metric tons. The Hst price for pure biotin in 1995 was — 7.00/g whereas, the Hst price for technical feed-grade biotin was — 5.50/g. Biotin is used in various pharmaceutical, food, and special dietary products, including multivitamin preparations in Hquid, tablet, capsule, or powder forms. One of the commercially available products of i7-biotin is Britrit-1, which is a 1% biotin trituration used in food premixes. 

Estimates of world demand iu 1979 were as high as 1300 x 10 lU of vitamin D. This was divided iuto thirds for Europe, the United States, and the rest of the world, respectively. Of this demand, 90% was estimated for animal-feed fortification and 10% for food and pharmaceutical uses. It is estimated that the demand will be 1500—1600 x 10 IU iu 1997 for animal usage and 100 x 10 IU for human use. The United States will require approximately 500 TU (1 trillion units = 25 kg i j -vitamin D or 17 t of resiu) for animal use and 30 TU (approximately 1 t of crystalline (7j -vitamin D ) for human use. This represents approximately 50 t of vitamin D resiu/yr for animal use worldwide and about 2.5 t of crystalline vitamin D for human use. A substantial proportion of the vitamin D is imported, and with all uses iucluded, it is estimated that 80—90% of the sales are of vitamin D. ... 

Agriculture consumes by far the most of any use category to which the accessible mnoff worldwide is appHed (Table 6). Postel and co-workers estimate that human uses make up 26% of total terrestrial evapotranspiration and 54% of the mnoff geographically and temporally accessible (9). Increased use of evapotranspiration will confer minimal benefits globally because most of the land suitable for rain-fed agriculture is already in production. New dam constmction could increase accessible mnoff by about 10% over the next 30 years however, population increase during that period is projected to be more than 45%. 

Of the surface of the earth, 71% (3.60 x 10 km ) is covered by oceans their average depth is 6 km and their volume is 8.54 x 10 km . Unfortunately, this huge quantity of water is not suitable for very many human uses. Water with over 1000 ppm (parts per million by weight, or mg/L) salt is usually considered unfit for human consumption, and water with over 500 ppm is considered undesirable, but ia some parts of the world, people and land animals are forced to survive with much higher concentrations of salts, sometimes of over 2500 ppm. 

The oceans hold about 97% of the earth s water. More than 2% of the total water and over 75% of the freshwater of the world is locked up as ice ia the polar caps. Of the remaining 1% of total water that is both Hquid and fresh, some is groundwater at depths of > 300 m and therefore impractical to obtain, and only the very small difference, possibly 0.06% of the total water of this planet, is available for human use as it cycles from sea to atmosphere to land to sea. Only recently have humans been able to regulate that cycle to their advantage, and even now (ca 1997), only infinitesimally, ia some few isolated places. 

Most polymyxin B sold for human use in the United States is in dermatological, otic, and ophthalmic preparations that usually contain one or more other spectmm extending antibacterials such as bacitracin, neomycin sulfate [1404-04-2], C23H4gNg023, linear gramicidin, oxytetracycline [79-57-2],... 

The metal lost from the inside of pumps, reaction vessels, pipework, etc. usually contaminates the product. The implications of this depend upon the product. Ppb levels of iron can discolor white plastics, though at this level the effect is purely cosmetic. Ppm levels of iron and other metals affect the taste of beer. Products sold to compositional requirements (such as reagent-grade acids) can be spoiled by metal pick-up. Pharmaceutical products for human use are often white tablets or powders and are easily discolored by slight contamination by corrosion products. 

With the exception of ruthenium and chromium, all the materials mentioned for automotive catalysts are lower than lead in toxicity (74). The danger to human use is minimal, except during manufacturing and installation of the catalysts where safety precautions can be adequately controlled. 

Levine BL, Humeau LM, Boyer J et al (2006) Gene transfer in humans using a conditionally replicating lentiviral vector. Proc Natl Acad Sci USA 103(46) 17372-17377... 

The effects of leukotrienes can be blocked at several levels. Inhibitors of FLAP or 5-LO inhibit LT synthesis at all levels. However, FLAP antagonists developed to date have been too hepatotoxic for human use. Zileuton, a 5-LO synthase inhibiting drug, also demonstrated some hepatotoxicity in a small percentage of patients, which was nonetheless entirely reversible. However, the short half-life of this compound requires four times daily... 

In 1938, Congress passed this law that gave the FDA control over the manufacture and sale of dru, food, and cosmetics. Before the passage of this act, some drugp, as well as foods and cosmetics, contained chemicals that were often harmful to humans. This law requires that these substances are safe for human use. It also requires pharmaceutical companies to perfonn... 

EC Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. 

Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC Amended by Commission Directive 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use... 

Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products... 

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