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Had this been done in concomitance with the initial proposal of 'substantial equivalence' - based regulation in the early '90s, stakeholders might have been better informed, and the final harmonization reached earlier.
All authors participated in the review of the back translation and final harmonization.
The last phase of the translation process included research group discussions about the reconciliation, back translations, and final harmonization.
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The results of the corpus harmonization process was that 1,185 annotations were added to the original 24, 671 test set annotations (4.08%) while 505 (2.05%) where removed, obtaining the final harmonized test set of 25,351 annotations.
In the final instance, codon harmonization of the full gene sequence of MSP142 yielded the highest level of soluble protein compared with both the single-pause-site mutant and the 5′-end harmonized variants (Fig. 1, lane 3, and Fig. 2D) [ 62, 63].
Finally, to achieve strategic civilian-military harmonization, we have to first get the maps straight.
In a discussion session held during the consortium's final meeting, several participants noted that the shared goal of harmonization of methods and results across laboratories encouraged participants to fully engage with the planning process and to scrupulously follow the protocols to avoid being an outlier.
The final method was validated using methodology described by the International Conference of Harmonization in the field of Active Pharmaceutical Ingredients.
To illustrate the influence of the stability of the test substance on the final experimental outcome, we performed a short-term International Conference on Harmonization (ICH -based stabICH -basedy of cyclophostabilityin the culture medium, to which a marine flatworm model Macrostudym lignanofis exposed.
A code book (harmonization guidelines) was made explaining how the variables were harmonized (see additional file 1: Harmonization guidelines).
10 Final Review and Documentation (Proofreading) Ensure proposed revision maintains conceptual equivalence and does not threaten international harmonization for future data pooling purposes, implement revisions, proofread revised translations, and document any relevant alternatives in the Item Definition Table.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com