Biological testing procedures

The third health effect bioassay employed utilizes acute toxicity in whole animals (rats). Since the major objective of the Level 1 biological testing procedure is to identify toxicology problems at minimal cost, a two-step approach is taken to the initial acute in vivo toxicology evaluation of unknown compounds. The first is based on a... 

Elastomeric closures for injections, biological test procedures, physicochemical... 

Biological test procedures that can be used for solid samples such as waste, soils and sediments have been developed already (see Section 9C.3 below and Chapter 6). 

Also, Article 9 of the BBodSchV (harmful soil changes in the context of risk assessment), Paragraph 1, Point 2 (considerable accumulation of pollutants that, due to their toxic properties, are particularly relevant for introducing harmful soil changes), may serve as a legal basis for the development of biological test procedures. 

Extractives. Tests may be derived from directives, compendial standards, World Health Organisation, etc., with limits/ standards based on chemical or biological test procedures. Such tests can provide useful comparisons but final approval can only be based on tests where contact between product and pack is involved. 

CRITERIA FOR ECOLOGICAL ASSESSMENT AND BIOLOGICAL TESTING PROCEDURES... 

Aconitine produces an intense tingling sensation when a drop of a solution, 1 in 10,000, is applied to the tip of the tongue. It also gives a characteristic unstable, crystalline precipitate when a few drops of potassium permanganate solution are added to a solution of the alkaloid in dilute acetic acid. The formation of acetic acid when the alkaloid is heated dry, or of benzoic acid when it is hydrolysed by alkali, have also been suggested as identification tests. For the recognition of minute quantities a biological test is probably the best procedure. ... 

Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products... 

The previous sections have summarized the basic techniques available for searching chemical databases for specific types of query. Another important database application is compound selection, the ability to select a subset of a database for submission to a biological testing program. The selection procedure can be applied to in-house databases, to externally available compound collections, or to virtual libraries, that is, sets of compounds that could potentially be synthesized. 

Extraction procedures must be adjusted when separated anthocyanins will be tested in biological studies. We have found that the types of acids used for anthocyanin extraction as well as their residual concentrations in the final extract may affect the results obtained from biological tests. The growth inhibitory effect of anthocyanins on HT29 (human colonic cancer) cells may be overestimated if the residual acid in the extract exerts a toxic effect on the cells. Acetic acid residues in anthocyanin extracts showed less toxicity to HT29 cells than hydrochloric acid when samples were prepared under the same extraction procedure and subjected to the same tests on HT29 cells. In addition, the procedure to remove acids affected the acid residual concentration as well in final anthocyanin extracts, with lyophilization being more successful than rotary evaporation. 

Also, the test procedure (protocol) is fundamental because it allows comparing results from different laboratories and from different experimental sets. Moreover, selected test protocol could affect the interpretation of the results, the information content and its application in the safety evaluation process, as stated by Frazer if the biological system is exposed to a test chemical for 24 h and the endpoint assay is immediately conducted, the data produced would be most relevant to the acute toxicity of the test material. If, on the other hand, the system is exposed to material for 24 h and the system is cultured in the absence of the test material for additional 48 h before the endpoint assay is conducted, the data would be more relevant to recovery from toxicity rather than acute toxicity [7]. 

Many methods are available for determining food antioxidant capacity, which is an important topic in food and nutrition research. However, there is a great need to standardize these methods because the frequent lack of an actual substrate in the procedure, the system composition, and the method of inducing oxidation could limit their accuracy. In fact, antioxidant activities in complex systems cannot be evaluated satisfactorily using a single test, and several test procedures may be required. The search for more specific assays that can be more directly related to oxidative deterioration of foods and biological systems should be the objective of future investigations. 

Biotechnological/Biological Products Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products Notice Draft Guidance on Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances Notice... 

FDA (1999). ICH harmonised tripartite guideline. Specifications Test procedures and acceptance criteria for biotechnological/biological products. Fed Regist 64 44928. 

Part II Part II is the report concerning chemical, pharmaceutical, and biological documentation. The report details the composition, method of development of formulation, manufacturing processes under GMP, analytical test procedures, bioavailability, and bioequivalence. It should be noted that all analytical test procedures need to be validated, and the validation studies must be provided. 

B94001 Guidance for the Determination of Appropriate Methods for the Detection of Section 313 Water Priority Chemicals 821F03009 Guidelines Establishing Test Procedures for the Analysis of Pollutants Analytical Methods for Biological Pollutants in Ambient Water Final Rule [Fact Sheet]... 

The test procedure can be performed by pumping HPLC grade water at a specified flow rate under a controlled back-pressure, using a commercial back-pressure device connected in-line just after the pump. A f 000 psi back-pressure device is recommended. It is also advised that about f % MeOH be added to the water in order to minimize biological growth. While timing the process with a calibrated stop watch, the pump effluent should then be collected in a volumetric flask. From this, one can calculate the actual solvent flow at each flow rate. 

The major emphasis in environmental measurements over the past 2 years has been on development of procedures for Level 1. As presently conceived. Level 1 is structured to produce a cost-effective information base for prioritizing streams and for planning any subsequent programs. The specific procedures applied are detailed in two published manuals, the first covering sampling and chemical analysis (4) and the second biological tests (5). Application of the complete battery of procedures provides input data to support evaluation of the following questions ... 

Duke, K. M., Davis, M. E. and Dennis, A.)., lERL-RTP Procedures Manual Level 1 Environmental Assessment, Biological Tests for Pilot Studies. U. S. Environmental Protection Agency Report, EPA-600/7-77-043, NTIS No. PB 268-484/AS (4/77). 

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Q6B Specifications Test Procedures and Acceptance Criteria for Biotechnological/Biological Products, 1999. 

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