The Bioanalysis Glossary


224. International Council for Harmonization of Technical Requirements for Pharmaceuticals for


Human Use (ICH) Formed in 1990, brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. It aims to achieve greater harmonization worldwide to ensure safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. It aims to achieve this through the development of harmonized guidelines that are adopted by member countries in place of local/ regional guidelines (ICH Guidelines).


225. interpolation The means of calculating the concentrations of incurred and quality control samples (QCs), through the established back- calculated line of regression of nominal concentration against instrumental response.


226. intra-assay accuracy Accuracy as it pertains to bioanalytical validation, typically from a mean of six replicates within a single analytical run as compared to a corresponding nominal concentration.


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Bioanalysis (2020) 12(21) Suppl. 1


future science group


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