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In the methodology development phase, CNVplex® detected all copy number aberrations that were previously identified with both chromosomal microarray analysis and MLPA, demonstrating 100% sensitivity and specificity.
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This can be achieved during the development phase encompassing Phase I-IND/CTA/CTandNDA/WMAWMA filing and the derived alternative shelf life methodology made applicable for later bulk manufacturing process. .
This can be achieved during the development phase encompassing Phase I-IND/CTA/CTandNDA/WMAWMA filing and the derived alternative shelf life methodology made applicable for later bulk manufacturing process.
The methodology is in its development phase and its applicability in industry has been mainly tested in one specific context.
In the questionnaire development phase, methodology based both on CTT and IRT was used, thus yielding complementary results that reinforce the robustness of the data.
The consensus panel methodology used in the development phase allowed us to select PIP criteria and alternative treatment options that were prevalent and considered clinically relevant to Irish primary care.
As with the development phase, the validation study methodology closely followed the guidelines laid out by the FDA for the development of a PRO measure [ 16].
Although various methodologies have been developed for the ECU verification at the development phase, the ECU verification in the manufacturing phase has rarely been brought into focus.
The development phase of the tool followed a standardised methodology [ 27] as well as regulatory authorities' recommendations, with involvement of all parties who are ultimately targeted by the tool, i.e., patients and PCPs [ 34, 35].
Phase 1 involves project start-up, district selection and methodology development.
This paper will propose a technique and research methodology that can support TRL in technology maturity assessment in the design and development phase of a technology lifecycle.
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