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Therefore, the comparability studies should be well designed, including both non-clinical and clinical studies.
Drug substance (DS) color is an important quality attribute for release, stability and comparability studies of biologics.
However, due to the general complexity and heterogeneity of mAbs, comparability studies between SBP and RBP are challenging.
Inter-assay comparability studies have been performed, but the robustness of type-specific results has neither been emphasized nor has the degree of intra-assay reproducibility been addressed.
An overview of comparability studies can be found in Wang and Shin (2009), and in a review of literature from the Texas Education Agency (2008).
A discussion of the different functions of the two modes regarding practice effects has implications for the design of comparability studies.
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"When the baseline assessment was proposed we were clear that we would carry out a comparability study of the programme.
Employers expect to obtain from the Government today a "form of words" about the setting-up of a pay comparability study.
However, the comparability study found that the tests offered by CEM and NFER – which included children answering questions on tablets – also showed wide variations in outcomes.
A phenomenally successful day of action by 1.5 million council, health service, and university manual workers has given Britain a taste of things to come as the public service unions pursue their demands for an immediate "going rate" pay rise and a pay comparability study.
In addition, it could be useful in biological characterization studies for antibody minor variants, process optimization, and comparability study at later stages of antibody development.
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