Veterinary development process

As mentioned previously, normally animals cannot self-medicate (exceptions are feed additives, insect dusters) and iimovative solutions must be devised by the veterinary formulation scientists to assure that their final products can be administered safely, quickly, and easily by the end user. Thus the means of administration must be carefully considered and be part of the product development process (53). 

The previous chapters examined the process for the development and authorisation of a drug product containing a ne v active ingredient for human use. This represents the most arduous path to market for any medicinal product. This chapter proceeds to examine the process of bringing a veterinary medicinal product to market. While the process shares most of the principles that apply to human drugs, there are some additional features that are unique to veterinary products. These include methods of use and the requirement to evaluate vithdra val periods and maximum residue limits in food-producing species. 

The process of developing and bringing to market veterinary medicines is fundamentally the same as that for human medicines. However, there are a number of features associated with veterinary medicines that can have either a positive or negative bearing on the overall process. 

Although, MediChem is a biosecurity products manufacturer, its biotechnology-based R D capabilities are worth mentioning here. The attended markets include Medical, Laboratory, Veterinary, and Environmental sectors. Medicinal chemistry services and drug discovery form the basis of the company, though their capabilities might be applied in a broader range of sectors. These capabilities comprise the areas of Proteomics, Combinatorial and Computational Chemistry, Medicinal Chemistry, Enzymes, Process Development, Analytical and Separations Chemistry, Chemical Synthesis and Scale Up. 

Substances used only for process-orientated research and development are exempt from registration for 5 years. The exemption can be extended for a further 5 years in exceptional circumstances, or 10 years for substances used exclusively to develop human or veterinary medicines. The manufacturer or importer has to inform the ECA of the substance identity, labelling and quantity, justify the quality, summarise the research programme and list the customers. 

The ways of SC appliance in veterinary are numerous, including the fundamental biology and applied veterinary. The ESC of different animal species are irreplaceable model for investigating the mammalian embryo-genesis. Since the ESC are totipotent, they can be used as the convenient in vitro model for the investigating of cytodifferentiating processes in the mammalian development. 

The future development of aminoglycosides for use in veterinary medicine will depend on two main factors. The first is the cost of producing them as the synthetic process is expensive. The second is depdendent on discovering an aminoglycoside that does not accumulate and remain in kidney tissue for prolonged periods, resulting in a shorter withdrawal period for food producing animals (11). 

ABET believes that the technology has applications in medical centers, veterinary schools, pharmaceutical companies, and state and federal governmental research and testing agencies. According to the developer, the WR process has the following advantages ... 

Miyauchi, A. (1998). A commercial application of EBA in a veterinary pharmaceutical production. Development of recombinant epidermal growth factor production process using Bacillus brevis. Int. Conf. Expanded Bed Adsorption, 2nd, Napa Valley, CA, 1998, Abstr. 0.03. 

A 25-year-old veterinary practitioner developed an inflammatory demyelinating process affecting the... 

In this chapter the subject of scale-up is reviewed, which is taking small laboratory cultures (e.g. 10 ml) to industrial-scale processes (e.g. 10 000 litre), i.e. a 1 000 000-fold scale-up The aim of such scale-up is to provide more cells, and more cell product, in as efficient and cost-effective a manner as possible. Cell cultures have been used since 1954 for the production of human (e.g. polio, measles, mumps, rabies, rubella) and then veterinary (e.g. FMDV) vaccines (Griffiths, 1990a). Interferon was the next most important product to be developed, followed by monoclonal antibodies and a range of recombinant proteins. 

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