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Under a Food and Drug Administration directive, we examined definite long-term safety and efficacy aspects of an engineered diaphragmatic tendon graft as a regulatory prerequisite for clinical trials.
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The factors that influence this development are technology development, demographic changes, economical, and regulatory prerequisites.
In respect to planned autologous and allogeneic APOSEC production strict regulatory prerequisites (e.g., virus inactivation, potency assays, and mandated GMP facilities) have to be met in order to reach human clinical trials.
Adequate validation, with an assessment of robustness (sensitivity analysis) and predictive performance of the model is a prerequisite for regulatory acceptance.
During cell differentiation, the high complexity level of transcriptional regulatory networks is a prerequisite for the orchestration of the time-controlled initiation of the proper transcriptional programs.
Sterility, or low bioburden, is likely to be a prerequisite for regulatory approval, while MN arrays must be capable of being produced in a range of sizes to suit required drug doses.
An efficient cross-border investment and well-designed markets and regulatory instruments are crucial prerequisites to the creation of a fully functional European internal electricity market.
To reveal the regulatory effect of SNPs, prerequisites of the number of related SNPs located in a gene' s expanded gene region were used to filter some probes, and the threshold of SNP quantity we used here was 6.
Scientific validation is a necessary prerequisite for the regulatory acceptance of new toxicological tests, and for acceptance as Organisation for Economic Co-operation and DEconomic Co-operationlinEconomic Co-operation
Consequently, the correct selection, use, and maintenance of cleaning equipment and systems by the food industry is essential to minimize the risk of microbial, allergen, and foreign body cross-contamination, and thus aid compliance to relevant regulatory and legal requirements, HACCP prerequisite programs, and audit standards.
Sprouty phosphorylation on the conserved tyrosine is considered as an indispensible prerequisite for the regulatory function of Spry1 and Spry2 [ 99, 103], but not for that of Spry4 [ 72, 76, 89].
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com