Animal health products

Economics-According to the Animal Health Institute s (AHI) 2000 Domestic Sales Survey, sales of animal health products in the United States for 1999 totaled 4.32 billion priced at the manufacturer s level [1]. 

This dosage form will be most familiar to the pharmacist since it is used for companion animals (dogs and cats) and is sold in most drugstores, supermarkets, and animal health product centers. There are two types of flea and tick collars, also known as slow-release pesticide generators vaporous and powder-producing collars. Both contain the insecticide and a plasticized solid thermoplastic resin. 

H. L. Newmark and E. DeRitter, Animal Health Dosage Forms Stability Requirements, in Animal Health Products Design and Evaluation (D. C. Monkhouse, ed.), American Pharmaceutical Association, Washington, DC, 1978, p. 133. 

The market for animal health products is estimated to be over 2 billion in the U.S, and nearly as much in Western Europe Antibiotics dominate the animal health market, and feed additives account for about 50% of that market. 

Animal health is a segment of the life sciences industry at the interface of pharmaceuticals and agrochemicals. Global sales were 15 billion in 2005 ( 14.5 billion in 2004, 13.8 billion in 2001, inflation-adjusted). Of the top 10 companies, 9 are business units or spinoffs from pharmaceutical companies (see Table 11.9). The industry is rather concentrated, with the top 10 companies accounting for 75% of total sales. As they do in pharma, US companies dominate in animal health products. Many of the veterinary products in the portfolios had originally been developed for human use or as pesticides. In the pet (respectively companion animal) segment, which comprises cats, dogs, birds, some rodents, reptiles, and horses and represents about 40% of the total market, the association with human health is particularly prominent. 

After the United States, Japan is the second largest consumer of animal health products. In 1990, 110 feed additives were approved for use in Japan and production reached 78,000 tons estimated to be worth 60,000 million yen. 

Agricultural Division Animal Health Products 12707 Shawnee Mission Pkwy. Shawnee Mission, KS 66201 (800) 255-6517 FAX (913) 268-2803... 

Chemicals Manufacturing Pharmaceuticals Animal Health Products Synthetic Materials Crop Science Plant Biotechnology Health Care Products... 

Vertex business is divided into six categories Technical Components, Dairy, Industrial Containers, Household Products, Food Trays and Securefresh. Processes include rigid blow-moulded containers for industrial, household, chemical and agricultural products extruded sheet and thermoformed containers for food manufacturers, kiwifruit and horticultural products disposable and point-of-sale packaging for the food service sector and injection-moulded components for human and animal health products. 

The average effective patent protection for human and animal health products approved in the USA between 1984 and 1989 was only 10... 

Comparable figures with reasonable validity for animal health products are not available. Veterinary product development cost are definitely lower, but the revenues are also much lower. Due to rising registration demands, influenced by both the pharmaceutical and the agricultural sector, veterinary product development cost follow the same trend as human health products. 

SECONDARY METABOLITES AS A VITAL SOURCE OF ANIMAL HEALTH PRODUCTS... 

Biodiversity New Leads for the Pharmaceutical and Agrochemical Industries reviews and discusses aspects of modern natural products research. The central theme of many articles is the sustainable use of global biodiversity. Microbial, plant and marine products are presented as the sources of new drugs, including anti-fungal products, antibiotics, anti-cancer agents and animal health products. There is also coverage of the biosynthesis of polyketides and the chemical synthesis of natural products and their derivatives. 

Bezimidazole animal health products are often related to crop protection chemicals. The first one, made from o-aminoanthranilic acid72, was thiabendazole (112), discovered by Merck in 1961. However, 112 undergoes rapid enzymatic hydroxylation. This is overcome when the thiazole ring is replaced by a 2-methylcarbamate substituent in parbendazole (113), patented in 1973. Concerns over tetrogenecity have led to restrictions in the use of 113 and its derivatives in pregnant animals. 

Diphenylamine (8) is readily converted into phenothiazine (111), an inexpensive product useful in the treatment of human schistosomiasis (caused by blood and liver flukes), already discussed under animal health products. The salicylanilide oxyclozonide (142) came to prominence in the 1970s. Another schistosomal agent is the metabolite of lucan-thone (143a), namely hycanthone (143b). 

Similarity is seen between human and animal health products in analytical testing conducted to assure the quality attributes of the final product. The validation of these assays is identical in that linearity, precision, accuracy, robustness, and reproducibility are aU required. Two examples of analytical areas that may differ include stability and in vitro drug testing. 

Stability testing The unique stability testing requirements for animal health products include stability protocols that account for package size, extremes in exposed temperatures, in-use or broach packages, blending with other components (e.g., feeds), and compatibility with unique dosing devices. 

Both human and animal health products need to be safe, efficacious, and of defined quality. For major markets in the world, both animal and human products need to be manufactured in GMP facilities. For human products, regulatory requirements are set for the areas of toxicity, safety, dosing intervals, therapeutic effect, stability, manufacturing, etc. Veterinary products not only include all of the above but are also required to address tissue residue, handler safety, and environmental assessment, particularly if the product is for food-producing animals. If producing a new antimicrobial agent for food-producing animals, the issue of antimicrobial resistance also needs to be addressed. Details about these special requirements were covered in section Residue of this chapter. 

In this chapter, pharmaceutical and health-care products, such as prescription drugs, generic drugs, OTC products, animal health products, dietary supplements (vitamins and herbal drugs), and biotechnology-derived products, are discussed in relationship to the format of preformulation reports. Topics of the preformulation study are discussed in detail. Models for some of the reports are provided in the hope that the pharmaceutical development team will devise an individual report format based on particular needs and resources. Analytical techniques useful for preformulation and regulatory conformity or requirements relative to product registration processes are also enumerated. 

Merck is a global research-driven phannaceutical company that discovers, develops, manufactures, and markets a broad range of human and animal health products. In addition, the company manufactures specialty chemical and environmental... 

The life science activities comprised a number of wholly and partially owned companies producing pharmaceuticals, agrochemicals and animal health products. A separate company called Rhodia was set up in June 1998 to operate in the field of specialty chemicals (fine organics, consumer specialties, industrial specialties, polyamides). 

Animal Health Product Development, Central Research Division, Pfizer Inc., Terre Haute, IN 47808... 

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