 CombiStats is intended for use by persons responsible for the analysis of assays data but whose primary training is not in statistics and who have no access to expert statisticians to assist them with the analysis. The software may be used in any situation where the analysis of data from dilution assays is required but it is primarily intended for use in the context of monographs of the European Pharmacopoeia. The assays described in the European Pharmacopoeia have usually been elaborated with the intention that simple statistical methods such as parallel line analysis, probit analysis, etc. can be used to evaluate the results from these assays without the help of a statistician. The appropriateness of the described methods and models have normally been assessed in collaborative studies in which a representative number of laboratories have participated. As a result, the described statistical methods can be considered suitable for regulatory purposes, but it would be a mistake to assume that they represent in all cases the most sophisticated way to evaluate and model the data. It is therefore stressed that CombiStats is not in the first place intended for research and/or development although it may in specific cases be suitable for that purpose.
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