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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.
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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.
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.
As Tim Duncan of the Cambridge Winter Center for Financial Institutions Policy emphasized with me in conversation, there were plenty of Bush-appointed regulators who would have been rejected if "management experience" were a prerequisite for regulatory chiefs.
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.
Prerequisites: All required regulatory science courses and three elective courses, which must include 410.802 Independent Studies in Regulatory Science and, if hypothesis driven, 410.645 Biostatistics.
As a consequence, regulatory agencies have introduced additional prerequisites for the evaluation of the safety of new antidiabetic agents.
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