And animal experiments

Paper mill whitewaters and effluents are rich in bisphenol A (BPA), which is used in great quantities for the production of epoxy resins and polycarbonate plastics. Its presence in effluents has been reported as a result of its use in the manufacture of thermal paper or due to migration from plastic containers at the high water temperatures of whitewaters [35]. This compound is preferably analysed by GC-MS. The levels encountered in paper mill effluents are between 28 and 72 pg/L [36,37]. Another study revealed levels up to 226 pg/L [33]. Special in vitro test systems and animal experiments have demonstrated a weak oestrogenicity for BPA. Since aquatic wildlife could be endangered by paper mill waste discharges at the concentration that BPA is found, its survey in paper mill effluents should be taken into consideration. 

We thank Dr. Jerome and Dr. Nahde for helping with the cell culture and animal experiments and Dr. Merdan for the confocal laser scanning microscopy experiments. We would also like to thank vectron therapeutics... 

In general, bioequivalence is demonstrated if the mean difference between two products is within 20% at the 95% confidence level. This is a statistical requirement, which may require a large number of samples (e.g. volunteers), if the drug exhibits variable absorption and disposition pharmacokinetics. For drugs for which there is a small therapeutic window or low therapeutic index, the 20% limit may be reduced. The preferred test method is an in vivo crossover study and, since this occurs in the development phase, necessitates the emplo)unent of volim-teers. These studies are, therefore, expensive and animal experiments may be substituted, or in vitro experiments if they have been correlated with in vivo studies. 

Cantell, K., S. Hirvonen, K.E. Mogensen, and L. Pyhala, Human leukocyte interferon production, purification, stability, and animal experiments. In vitro Monogr, 1974. 3 35-8. 

Papers presented earlier In this symposium described a number of approaches which were used to determine bloavalla-blllty of dietary zinc. Experiments with animal models and human subjects were reported. Most scientists agree that as much Information as possible should be first obtained from In vitro and laboratory animal experiments. However, since results of vitro and animal experiments do not always agree with results of human experiments, research with human subjects Is ultimately required to establish dietary requirements of humans and to determine bloavallabllty of nutrients to humans. 

The data shall prove the rationale for the combination and corresponding data shall be in principle generated from clinical triads and animal experiments. 

Since WWI, a large body of information on sulfur mustard toxicity has been reported from wartime accounts, accidental laboratory and industrial exposures, and animal experiments. Deliberate volunteer exposures of skin to minute amounts of mustard were commonplace in many countries through WWII however, realiza-... 

Toxicology studies are conducted to define the safety profile of a candidate and include definition of the no-observable-toxic-effect dose, maximum tolerated dose or MTD, potential organs of toxicity, and potential biochemical markers to detect and track toxic events. Most developmental compounds that do not become therapeutic products have unacceptable toxicity in animals and/or humans. Before the definitive toxicology studies needed to support an IND submission are initiated, a number of in vitro and animal experiments can be conducted to characterize the potential toxicity of the candidate. These early toxicology evaluations are usually conducted in the same species as used in pharmacology evaluations. As mentioned earlier, the lowest dose that has no toxicity, or an acceptable level of toxicity, is compared with the dose that gives the desired pharmacological response in the same animal species to obtain a therapeutic ratio or index for that species. 

The physicochemical tests, in vitro methods and animal experiments used in the biopharmaceutical preformulation phase can never fully reflect the conditions in man, and studies of the drug absorption prerequisites can therefore be very valuable. This is especially relevant if (a) contradictory results have been obtained in model experiments, (b) the substance has complicated absorption properties (e.g., active transport) or (c) a modified release formulation will be developed. The most important information that can be obtained in such human studies is... 

The Royal Commission on Environmental Pollution reported in 1996 that it was not aware of any study that provided firm evidence of adverse effects of contaminated land on health.10 However, the potential for health effects is real. Exposure to chemicals is a risk factor for several diseases and the International Agency for Research on Cancer has classified over 70 chemicals as human carcinogens, 60 as probable and more than 200 as possible carcinogens.11 There is evidence of an environmental influence in human diseases such as cancer,12 including geographic variation in cancer incidence in migrant populations, occupational studies and animal experiments. A number of studies also appear to suggest an association between other health effects and exposure to environmental chemicals. There are thousands of sites contaminated with hazardous chemicals with the potential to expose human populations. In the USA, the ATSDR has estimated that 46 % of the assessed National Priority List sites represent an actual hazard to health.13... 

Obama K. 1996. Studies on allergic skin disease caused by pesticides in citrus growers Eield survey study and animal experiments. Med J Kagoshima Univ 48 13-22. 

Cell culture and animal experiments offer further evidence of the protective effect of lycopene against DNA oxidation. In cell culture, lycopene supplementation decreased levels of both 8-OHdG and lipid peroxidation induced by FeNTA/ascorbate [82]. Subsequently, this effect was also demonstrated in vivo. Rats treated with ferric... 

Takeo G, Shibuya N, Motomura M, Kanazawa H, Shishido H. A new DNA gyrase inhibitor induces convulsions a case report and animal experiments. Chemotherapy (Tokyo) (1989) 37, 1154-9. 

The industrially produced carotenoids are virtually insoluble in aqueous media. It was therefore a great challenge to develop water-dispersible preparations for the food and feed sector. As has been shown by application tests and animal experiments, sufficient colouring intensity and maximum bioavailability can be achieved by reducing the particle size to less than 0,5 xm. Fig. 2 shows the effect of particle size on the UVA is absorption spectrum of (3,P-carotene (3) in water [95]. The structure and size of particles in the submicrometre range are studied by electron microscopy, dynamic light scattering, microelectrophoresis and UVA is spectroscopy. 

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