Rampazzo P
Fidia Farmaceutici, Abano Terme, Padova.
Farmaco. 1990 Jun;45(6 Suppl):807-15.
It is suggested a general scheme for the Validation of the analytical methods and some aspects of the parameters composing it are remarked. Furthermore, the procedure for the Standardisation is briefly discussed and it is highlighted the importance of two particular aspects (the calibration of the instruments and the Standard substances) that, even though not directly related to Validation, significantly affect its results.
本文提出了分析方法验证的总体方案，并阐述了构成该方案的一些参数方面。此外，简要讨论了标准化程序，并强调了两个特殊方面（仪器校准和标准物质）的重要性，尽管它们与验证没有直接关系，但会显著影响验证结果。
