Standardisation, biological

The test was originally developed for direct contact sediment testing but efforts are made to evaluate the method for its application to soil. The advantage of the test is its availability as testkit including the availability of standardised biological material. Furthermore, the test duration is rather short compared to other invertebrate tests. 

Table 6.2.2 List of presently available ISO standardised biological tests with whole organisms for the detection of envuonmental pollutants in water and sediments...

For substances that are standardised biologically, biological units are allowed. According to the international system (SI) only the International Unit may be abbreviated (lU). All other units should be written in fuU. In the UK the National Patient Safety Agency has recommended that even lU is not used but should be written out in full [11]. This was due to a number of deaths that have occurred owing to errors with abbreviations of (international) units. Also in other countries errors in dosing were discovered, due to lack of clarity in the necessary calculations from mg to USP units [12]. 

A. Siddiqui, in G. Papaevangelou and W. Hennersu, eds., Developmental biological Studies of Standardisation in Immunophjlaxis of Infections hy Hepatic Viruses Vol. 54, S. Kaigei, Basel, 1983, p. 19. 

The above example illustrates the inherent problems that can arise in the use of standardised protocols for assessing chemicals naturally occurring in the food chain. Had work on comparative metabolism and pharmacokinetics been undertaken before any animal bioassay work, it could have given more useful information. The extrapolation of effects obtained in high-dose animal studies to a large number of people exposed to a low dose is not the most effective use of resources. Nor are such experiments consistent with biological reality. There are few chemicals that would not cause illness or death if the daily intake was increased some 100-1000 fold as is the situation in many... 

Following concerns on impurities and standardisation, the Therapeutic Substances Act was passed in 1925 with the aim of regulating the manufacture of biological substances, providing the standards to which they must conform and... 

Voltolini S, Modena P, Minale P, Bignardi D, Troise C, Puccinelli P, Parmiani S Sublingual immunotherapy in tree pollen allergy. Double-blind, placebo-controlled study with a biologically standardised extract of three pollens (alder, birch and hazel) administered by a rush schedule. Allergol Immunopathol 2001 29 103-110. 

Gupta, S. K. (1991a). Assessment of ecotoxicological risk of accumulated metals in soils with the help of chemical methods standardised through biological tests. In Trace Metals in the Environment (J. P. Vernet, ed.). Vol. 1, pp. 55—56. Elsevier Science Publishers, Amsterdam, The Netherlands. 

As with all biological systems, controlling variables to give reproducible results requires a lot of standardisation. A detailed background of the development of biodegradability testing in relation to surfactants is given in Karsa and Porter [5], Painter [6] and Swisher [7]. 

Biological assay (bioassay) is the process by which the activity of a substance (identified or unidentified) is measured on living material e.g. contraction of bronchial, uterine or vascular muscle. It is used only when chemical or physical methods are not practicable as in the case of a mixture of active substances, or of an incompletely purified preparation, or where no chemical method has been developed. The activity of a preparation is expressed relative to that of a standard preparation of the same substance. Biological standardisation is a specialised form of bioassay. It involves matching of material of unknown potency with an International or National Standard with the objective of providing a preparation for use in therapeutics and research. The results are expressed as units of a substance rather than its weight, e.g. insulin, vaccines. 

Senna, available as a biologically standardised preparation, is widely used to relieve constipation emd to empty the bowel for investigative procedures and surgery. It acts in 8-12 h. 

That insulin preparations should be both precise and of uniform strength all over the world is vital to the health and safety of millions of diabetics. Advances in technology now allow biological standardisation in animal irrsulin to be replaced by physicochemical methods (high performance liquid chromatography FIPLC). 

After intravenous administration of a tracer dose of thallous-201 chloride, the cation disappears quickly from the circulation, with a biological half-life in the blood of less than 1 min, as the T1 is rapidly taken up by different tissues, especially heart and skeletal muscle (Kazantzis, 1986 Pennal et al., 1992). In apparently healthy individuals subjected to standardised physical exercise on a bicycle ergometer before intravenous administration of T1 chloride (80 MBq), it was found that 3.9% of the... 

Igarashi, Y., Kawamura, H., Shiraishi, K. and Takaku, Y., Determination of Thorium and Uranium in biological samples inductively coupled plasma mass spectrometry using internal standardisation. J. Anal. At. Spectrom., 4 (1989) 571. 

Charton, E. Hormones the role of the european pharmacopeia. Alternatives to animals in the development and control of biological products for human and veterinary use. Dev. Biol. Standardisation (Basel, Karger) 1999, 101, 159-167. 

The biological standardisation programme. In Pharmeuropa Bio Council of Europe Strasbourg, France, July 1996 Special Issue 96-1. 

Those results indicate that plant drugs containing optically active compounds should be standardised. There is also a necessity to perform investigations into the biological activity of monoterpens enantiomers. 

Boraston R, Thompson PW, Garland S Birch JR (1984) Growth and oxygen requirements of antibody producing mouse hybridoma cells in suspension culture. Developments in Biological Standardisation 55 103-111. 

WHO Expert Committee on Biological Standardisation. Requirements for Use of Animal Cells as In Vitro Substrates for the Production of Biologicals. Technical Report Series No. 50 (in press). World Health Organisation, Geneva. 

Penders E., Wagenvoort A., de Hoogh C., Frijns N. and Kamps R., 2006. Standardisation, quality assurance and data evaluation of on-line biological alarm systems. 2. Algae Toximeter (BBE-Moldaenke, Kiel, D). KWR report BTO 2008.036, Kiwa Water Research, Nieuwegein, Netherlands, 57 pp. 

A strategy for the application of biological tests (partly standardised) and a useful concept for the evaluation of contaminated soils using bioassay data have been established by a DECHEMA working group [21]. Under certain circumstances these tests may be used also to characterise wastes. 

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