Study On Statistical Rules For Analytical Method Alternative

The study of analytical method alternative is an important part of the life cycle of analytical methods and the internal force of the change of analytical method alternative.Alternative research can accelerate the acceptance and transformation of new procedures,enrich drug detection methods and promote the improvement of drug detection technology,so as to ensure drug quality and drug use safety.Alternative research involves many regulatory documents.With the deepening of understanding of alternative research,the relevant regulatory guidelines are constantly expanding,developing and improving.However,there are still the following problems to be solved at present.(1)There are many types of drugs and analysis methods,which lead to unclear alternative classification of methods;(2)There are scientific problems in the comparison options and the statistical analysis methods used,which lead to the distortion of the results;(3)The experimental design of alternative analytical methods is not rigorous;(4)Insufficient sample size and low efficiency of the determination method lead to misjudgment of results;(5)Alternative research involves a lot of statistical knowledge,and there are few clear and operable alternative statistical operation norms;(6)There is a lack of simple and reliable tools for statistical analysis of alternative results.Based on the above problems and combined with the previous research progress,the following research works have been carried out1.1.Defining the classification of alternative method.According to the classification of product detection attributes,it is mainly divided into two kinds:the alternative research of the same attribute and the different attribute.According to the data types of detection results,it is mainly divided into two types:quantitative data alternative research and qualitative data alternative research.Quantitative data can be subdivided into three types:a)acceptable approach,b)performance equivalent approach,and c)result equivalent approach.The comparison of qualitative data is also called d)conclusion equivalence.a.Acceptable approach refers to the approach in which the new method can alternative the old method after strict validation.This approach greatly increases the risk of miscalculation of the method;b.Performance equivalence refers to the interval estimation of the equivalence and non-inferiority of accuracy and precision respectively within the range of use on the basis of the validation and specificity of the two methods,so as to know whether the new method is equivalent or better than the old method in terms of performance indicators;c.Results equivalence refers to the alternative of quantitative data on the continuous results of some samples detected by two methods;d.Conclusion equivalence refers to the alternative analysis of qualitative data on the conclusions of some sample test indicators using two methods.The above types of alternative are almost applicable to all the situations of the current statistical comparison of alternative research and further promote the scientific development of alternative research.2.Introducing a more scientific and effective way of test.In the past,difference test was used to compare the two methods.In this paper,equivalence test was innovatively introduced into the field of alternative research of the method.Equivalence test of accuracy was carried out when examining the performance indicators of the method.(The equivalence test formula of homogeneous materials is:(?)The equivalence test formula of non-homogeneous materials is:(?).At the same time,the non-inferiority test of precision was also investigated(The non-inferiority test formula for homogenous materials is:(?)The non-inferiority test formula for non-homogeneous materials is:(?)The two tests effectively prove the consistency between the new method and the old method in the range of interval.The comparison standard of alternative research is further standardized,that is,the new method can be alternatived only if the new method is equivalent or partially non-inferiority compared with the old method.3.Defining the experimental design protocol,sample size and power of the alternative research.Reasonable and feasible design schemes should be developed in advance for the study of alternative,and different design protocols should be developed according to the difference of alternative options.In the performance equivalence,two kinds of experimental protocols of homogeneous and non-homogeneous materials are provided.An experimental design for repeated determination of independent samples in result equivalence.The investigation of sample size is also a key element in experimental design.Neither small sample size nor low efficiency can fully explain the reliability of the conclusions obtained.This paper provides the calculation formulas of sample size and power according to different experimental designs,so as to ensure the rigor of alternative experiments5.Building the first statistical comparison software specifically aimed at the research of alternative methods in pharmaceutical field.Based on previous theoretical research,the combination of computer science to develop the study of alternative statistical software(ALTER),the solution to the current alternative statistical computing difficulty and the problem of insufficient statistical evaluation index,at the same time,with the legal sample and the professional statistical software for alternative results compare,verify the reliability of software is developed on the results and conclusions and authority,for the future of alternative research provides a convenient and practical method statistical toolsIn conclusion,this paper is an interdisciplinary study that intersects the statistical analysis with the method alternative theory in the field of drugs,and provides new ideas for the development and application of alternative research in the field of drugs,a new template for the statistical standardization of alternative research,and a new tool for future alternative research in laboratories.