药品抽样中样本数确定的商榷

Discussion on Definition of the Sample Size in the Drug Sampling

目的探讨国家《药品抽样指导原则》中,样本数确定可能存在的问题以及解决的办法。方法以概率论和数理统计原理诠释抽样样本数确定的理论基础。结果现行药物固体制剂抽样方法中,样本数的确定可能有悖抽样理论。结论应按照国家标准的相关抽样方案确定样本数。

Objective To discuss the problems about the defining of the sample size and the way how to settle down in the national guide rules of the drug sampling.Methods With the basic theories of probability and statistics,the defining processes of the sample size were explained.Results It was possible that the present processes for defining in the sample size of pharmaceutical solid products may not accord with sampling theories.Conclusion Defining of the sample size should be done with relevant sampling plan in our national standards.