Regulatory guidelines limitations

The degradation and formation of nonabsorbable drug complexes in the intestinal lumen is the third factor, in addition to dissolution and permeability, which could affect fraction absorption. Limitations of bioavailability due to these factors seem to be less frequent compared with the two other main factors. Regulatory guidelines for BCS-based biowaivers still ask for in vitro studies of luminal degradation in relevant test media, whereas specific binding studies are not required [17]. 

In addition to rodent studies, regulatory guidelines for pharmaceuticals require that repeated dose safety studies of up to nine months (in the United States, six months elsewhere) in duration be conducted in a nonrodent species. The most commonly used nonrodent species is the dog, followed by the monkey and pig. Another nonrodent model used to a limited extent in systemic safety evaluation is the ferret. The major objectives of this chapter are (1) to discuss differences in rodent and nonrodent experimental design, (2) to examine the feasibility of using the dog, monkey, pig, and ferret in safety assessment testing, and (3) to identify the advantages and limitations associated with each species. 

Regulatory guidelines for plastics for pharmaceutical containers also set limits for impurities other than additives. These are inorganic species (metallic and non-metallic) that can also be present in plastic containers, and their determination serves as a quality criterion for the plastic material. They may or may not be related... 

The regulatory issues are less well-defined for mycotoxins other than aflatoxins. But with increasing data on specific toxicity of Fusarium mycotoxins such as fiimonisins, regulatory guidelines are being considered for these toxins as well. For example, in the USA, advisory limits exist for deoxynivalenol (DON) at 5-lOmg/kg (5-10 parts per million ppm) in animal feeds [7]. 

Despite a sluggish start, the commercialized herbal industry is now blossoming in the United States. More than 500 different herbs are currently marketed in the United States, responsible for over 3.2 billion in sales in 1997. Limited regulatory guidelines and direct-to-consumer advertising have created a booming herbal market. Products are readily available in health food stores, supermarkets, and pharmacies, through... 

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