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  • Benefit-Risk Assessment in Drug Regulatory Decision-Making
    The Benefit-Risk Integrated Assessment (Figure 1, top) ties together all the dimensions in an overall analysis and provides a succinct explanation and rationale for the regulatory recommendation
  • Regulatory and safety integration An integrated model approach to . . .
    Current operating model Based on Quintiles’ extensive discussions with clients – from emerging to mid-size and large global biopharma – about how they manage their established products, one identified outcome was that typical approaches to managing safety, regulatory and benefit-risk for marketed products are siloed and ineficient In the current model, safety, regulatory, benefit-risk
  • Benefit-Risk Assessment for New Drug and Biological Products
    Benefit-risk assessment is thus integrated into FDA’s regulatory review of marketing applications for new drug and biological products 14 Broadly speaking, benefit-risk assessment in FDA’s
  • The Integrated Assessment of Marketing Applications (IAMA)
    Meetings and Milestones for the Integrated Assessment of Marketing Applications Benefit-Risk Scoping Meeting can be held in conjunction with the Filing Meeting as the default, provided 90 minutes
  • Benchmarking Drug Regulatory Systems for Capacity Building: An . . . - IJHPM
    Background Benchmarking has been increasingly used on drug regulatory systems to achieve sustainable pharmaceutical system strengthening This study aimed to identify the scope, tools and benefits of benchmarking regulatory capacities and the most recent development in such phenomenon Methods This study employed an integrative and critical review of the literature and documents on benchmarking
  • The Risk-Need-Responsivity model: evidence diversity and integrative . . .
    Abstract This chapter provides a theoretical account of several models of evidence-based supervision skills and practices, including the Risk-Need-Responsivity (RNR), desistance and Good Lives models The chapter explores the models’ principles by engaging extensively with the key conflicts, debates, attacks and counter-attacks that have characterised exchanges between key proponents of the
  • Advancing Structured Benefit-Risk Assessment in FDA Review
    The Benefit-Risk Integrated Assessment is a summary of the final regulatory decision It explains the reasoning behind the decision, integrates the analysis of the product’s benefits and risks, and explains how evidence and uncertainties helped reach the conclusion
  • Emerging Good Practices for Quantitative Benefit-Risk Assessment: A . . .
    Balancing the benefits of a health product against its risks is a complex evaluation requiring the availability of relevant and large sets of clinical data and the elaboration of a well-structured analytical framework Over the past decade, tools for health product benefit-risk assessments have been developed by health authorities to inform regulatory decisions For example, the European


















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