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Neither a biomarker nor a validated PRO that conforms to current regulatory guidance is currently available for the assessment of treatment benefit in IBS-D.
These studies are not designed to link cause and effect and currently are not directly applicable to current regulatory practices, but they may serve as a "hypothesis-generating exercise that will help sharpen the focus of research" (Elliot et al. 2001).
There is continuing concern that patient information leaflets, tailored to current regulatory requirements, fail to meet patients' needs.
The CE method for a pharmaceutical tablet formulation was further validated according to current regulatory requirements, with respect to linearity and range, precision, specificity, accuracy and limit of quantitation.
The collaboration of all relevant stakeholders and regulators to support changes to current regulatory frameworks to enable this, is proposed as the way forward, particularly as their complexity has been identified as the major hurdle to the implementation of co-digestion in the UK.
The big discrepancy in educational attainment of EC teachers in various sectors shown above is in part due to current regulatory status regarding entry-level teacher qualifications.
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It is essential to improve current regulatory frameworks and to adapt them to current knowledge.
There are limitations to the current regulatory approach to define clinical decision values (CDVs) for cTn.
Most of the epilepsy-specific PRO reviews conducted to date were published prior to the current regulatory guidance, and none have evaluated the extent to which PROs have been developed to the standard required by regulatory authorities.
By considering the societal flow of chemicals (Substance Flow Analyses), the overall aim of the analysis of this topic here is primarily to evaluate current regulatory contexts, so as to provide guidance on existing and possible future policy frameworks to stakeholders.
In January Verizon successfully challenged the FCC's power to use Section 706 to justify anti-discrimination rules in a ruling that led to the current regulatory malaise.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com