A code book (harmonization guidelines) was made explaining how the variables were harmonized (see additional file 1: Harmonization guidelines).
By publishing the harmonization guidelines, insight is given into (the interpretation of) all post harmonized data of the EPOSA study.
Method validation was performed according to the International Conference on Harmonization guidelines.
The developed UPLC method is validated as per International Conference on Harmonization guidelines with respect to system suitability, specificity, precision, sensitivity, accuracy, linearity, and robustness.
In addition, the validation of the developed method was conducted as per the ICH Internationall conference of harmonization) guidelines Q2 (R1).
In addition, a system suitability test was performed and response factors were determined, essentially following International Conference of Harmonization guidelines for the validation of analytical methods.
A high-performance thin-layer chromatographic method for simultaneous determination of nadifloxacin, mometasone furoate, and miconazole nitrate was developed and validated as per International Conference on Harmonization guidelines.
Study conduct was in accordance with Good Clinical Practices as required by the International Conference on Harmonization guidelines and in accordance with ethical principles of the declaration of Helsinki of 1975 (as revised in 1983).
A residual chloroform concentration of <20 ppm was detected that is in accordance with the International Conference on Harmonization guidelines whose limit for this solvent is 60 ppm [82].
In this chapter, some harmonization guidelines and best practices are defined for city officials and other data owners who are interested in providing and working with different spatial and non-spatial data sources.
The UV method was validated according to the International Conference on Harmonization Guidelines [27] in terms of linearity, precision, accuracy, and limits of detection and quantitation for meropenem were established.
