Sentence examples for regulatory evaluation from inspiring English sources

We describe the non-clinical tests required for a regulatory evaluation of abuse/dependence risks, i.e., drug-discrimination, intravenous self-administration and physical dependence liability.

Findings of this study support the incorporation of MT into the design and regulatory evaluation of created wetlands in order to enhance N cycling and removal.

This review summarizes relevant context in which HIV vaccines are being investigated and the six completed efficacy trials of various candidate vaccines and regimens, as well as the lessons learned from them relevant to regulatory evaluation.

The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects.

In fact, many of the larger policy challenges in the regulatory evaluation of several of these recent merger proposals surrounds the degree to which ratepayer benefits are created, and the degree to which ratepayer risks are reduced.

Detailed statistical criteria applied for the regulatory evaluation of individual drug trials are typically not available in the standard medical literature, but are accessable via the FDA's Summary Basis of Approval Documents (SBAs).

Finally, this new organization could help to increase the credibility of the regulatory evaluations by developing an explicit checklist to determine the rigor of regulatory analyses.

Although it is still arguable whether full mechanical support in stented lesions is mandatory during the first four months after implantation, it would certainly be a safety design parameter and a benchmark for regulatory evaluations based on the fact that there is insufficient human in vivo data available, especially the vessel wall mechanical properties during the healing/remodeling phase.

While regulatory evaluations of new AD treatments will focus on safety and efficacy [ 2, 4], economic data and cost-effectiveness modeling techniques are needed to inform payer evaluations.

Without broad agreement on objective means for determining the credibility of research and testing, public confidence in regulatory evaluations and product stewardship programs will not improve.

In addition, the reliability of scientific work used in regulatory evaluations of chemicals is likely to improve if greater disclosure leads to increased evaluation of data quality and that evaluation then leads to improved designs and generally higher-quality studies.