Human food-effect studies

HUMAN FOOD-EFFECT STUDIES AND AVAILABLE PHARMACOKINETIC METHODOLOGIES... 

Quart BD, Chapman SK, Peterkin J, Webber S, Oliver S. Phase 1 safety, tolerance, pharmacokinetics and food effect studies of AG1343—a novel HIV protease inhibitor. Abst. LB3. In Proceedings of the 2nd National Conference on Human Retroviruses and Related Infections. 1995 163. 

Most of the bacteria, yeasts, molds, and higher fungi of interest for SCP production are deficient in methionine and must be supplemented with this amino acid to be suitable for animal feeding or human food appHcations. Also, lysine—arginine ratios should be adjusted in poultry rations in which yeast SCP is used (62). Human feeding studies have shown that only limited quantities of yeast such as Candida utilis can be added to food products without adverse effects on flavor (63). 

Anesthetics. Ethyl amiaobenzoate [94-09-7] (benzocaiae), C2H22NO2, is the only anesthetic candidate that might allow spawned-out broodstock carcasses to be used for pet or human food. Studies are still required to determine which residues remain ia the carcasses (9). Electronarcosis is an alternative to chemical anesthesia that uses varying electrical frequencies to rapidly anesthetize fishes and allow gentie recovery. Electronarcosis has been used effectively on tilapia (Oreochromis sp.) and the common carp Cyprinus carpid) and the technique is being tested with other fishes (23,24). 

Human Health At present, studies on the impact of POPs on human health are very limited in China. Most of the existing literature is focused on dietary studies, as the food chain is considered a major pathway for POPs to effect human health. Information on human health effects such as body burden and metabolism is insufficient and generally extrapolated from modeling data because few doctors have been involved in research on POPs exposures in China. Other exposures through respiration and skin as well as air and soil are seldom studied. 

For biological products (the chemical) excipients are often overlooked. They, too, may have effects or side effects and can leave residues in animals that end up in human food. Their choice for a development product must be considered carefully. Either one uses ingredients with a well established quality and safety profile or one must face the fact that a variety of analytical and safety data have to be established for these excipients. Safety studies for new excipients may cost more than the safety assessment of the biological product itself. 

Current data suggest that fumonisins may have greater effect on the health of farm animals than on humans, because studies on the impact of levels of fumonisins in human food have not yielded significant correlations [127, 146]. The Mycotoxin Committee of the American Association of Veterinary Laboratory Diagnostics recommended that permissible levels of fumonisins (B,) in feeds be limited to 5 ppm for horses, 10 ppm for swine and 50 ppm for cattle and poultry. 

Food-effect bioavailability and fed bioequivalence studies Study design, data analysis, and labeling. In Draft Guidance for Industry, U.S. Department of Health and Human Services, Food and Drug Administration, October, 2001. 

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