Bolton S
J Pharm Sci. 1983 Apr;72(4):405-8. doi: 10.1002/jps.2600720421.
A method for establishing sampling plans for in-house limits that fix both the producer's and consumer's risks is presented for pharmaceutical systems in which both between-batch and within-batch variations are present. Such plans can always be constructed and require more or less sample assays depending on the variability of the process. The computations involve a numerical approximation to the bivariate normal distribution.
针对存在批次间和批次内变异的制药系统，提出了一种建立内部限度抽样计划的方法，该方法能同时确定生产者风险和消费者风险。此类计划总能构建出来，且根据工艺的变异性或多或少需要进行样本分析。计算涉及对二元正态分布的数值近似。
