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Showing 1–10 of 10 results
Advanced filters: Author: Hubert Leufkens Clear advanced filters

  • An analysis of recent approved and failed marketing applications for new drugs evaluated by the European Medicines Agency highlights the factors that are most likely to be associated with non-approval.

    • Michelle Putzeist
    • Aukje K. Mantel-Teeuwisse
    • Hans-Georg Eichler
    Comments & Opinion
    Nature Reviews Drug Discovery
    Volume: 11, P: 903-904

    • Daan Crommelin
    • Pieter Stolk
    • Hubert Leufkens
    Comments & Opinion
    Nature Reviews Drug Discovery
    Volume: 9, P: 99-100

  • The efficacy–effectiveness gap describes the difference in drug performance under clinical trial conditions versus real-life conditions. Here, the authors argue that this phenomenon is due to variability in drug responses. They discuss the underlying biological and behavioural reasons for this phenomenon and propose strategies to 'bridge the gap'.

    • Hans-Georg Eichler
    • Eric Abadie
    • Brigitte Bloechl-Daum
    Reviews
    Nature Reviews Drug Discovery
    Volume: 10, P: 495-506

  • Drug regulatory agencies face the challenge of striking the appropriate balance between the need for rapid access to new drugs and the need to obtain comprehensive data on their benefit/risk profiles. This article highlights the scientific and regulatory issues involved, discusses regulatory strategies to address these issues, and speculates on future directions, such as a life-cycle approach to drug regulation.

    • Hans-Georg Eichler
    • Francesco Pignatti
    • Alasdair Breckenridge
    Reviews
    Nature Reviews Drug Discovery
    Volume: 7, P: 818-826

  • Launching in 2025, the European Platform for Regulatory Science Research will bring together academia, regulators and other stakeholders to accelerate collaborative regulatory science research solutions.

    • Liese Barbier
    • Pierpaolo Moscariello
    • Anna Maria Gerdina Pasmooij
    Comments & Opinion
    Nature Reviews Drug Discovery
    Volume: 24, P: 485-486

  • Regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, Eichler and colleagues discuss the consequences of regulatory risk-aversion and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.

    • Hans-Georg Eichler
    • Brigitte Bloechl-Daum
    • Guido Rasi
    Reviews
    Nature Reviews Drug Discovery
    Volume: 12, P: 907-916

  • Adaptive marketing authorization approaches may, in some instances, replace traditional binary regulatory decisions on drug approval with progressive reduction of uncertainty about the benefit–risk profile of a drug through iterative evidence gathering and evaluation. How should the nature of such evidence be determined?

    • Jean Philippe de Jong
    • Diederick E. Grobbee
    • Hubert G. M. Leufkens
    Comments & Opinion
    Nature Reviews Drug Discovery
    Volume: 12, P: 647-648